Trial Outcomes & Findings for Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs (NCT NCT03733730)
NCT ID: NCT03733730
Last Updated: 2023-11-01
Results Overview
Post-surgical intraocular inflammation was defined as exacerbated intraocular inflammation within 180 days after IOL implantation, indicated by greater than or equal to 3+ aqueous cell within the first 14 days post-operative, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-operative, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2449 participants
Primary outcome timeframe
Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.
Results posted on
2023-11-01
Participant Flow
Subjects were enrolled at 37 investigative sites located in the United States and 1 investigative site located in Puerto Rico.
Cohort 1: Of the 478 enrolled, 25 subjects discontinued prior to attempted implantation. Cohort 2: Of the 1971 enrolled, 144 subjects discontinued prior to attempted implantation. This reporting group includes all enrolled subjects/eyes with attempted implantation (453/706 in Cohort 1) (1827/3417 in Cohort 2).
Unit of analysis: eyes
Participant milestones
| Measure |
Cohort 1
ACRYSOF IQ RESTOR Multifocal Toric IOL (+3.0 D or +2.5 D) implanted in at least one eye during cataract surgery.
|
Cohort 2
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in at least one eye during cataract surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
453 706
|
1827 3417
|
|
Overall Study
First Eye Attempted Implantation
|
453 453
|
1827 1827
|
|
Overall Study
First Eye Successful Implantation
|
453 453
|
1827 1827
|
|
Overall Study
Second Eye Attempted Implantation
|
453 253
|
1827 1590
|
|
Overall Study
Second Eye Successful Implantation
|
453 253
|
1827 1589
|
|
Overall Study
Safety Analysis Set
|
453 706
|
1827 3417
|
|
Overall Study
COMPLETED
|
451 703
|
1778 3334
|
|
Overall Study
NOT COMPLETED
|
2 3
|
49 83
|
Reasons for withdrawal
| Measure |
Cohort 1
ACRYSOF IQ RESTOR Multifocal Toric IOL (+3.0 D or +2.5 D) implanted in at least one eye during cataract surgery.
|
Cohort 2
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in at least one eye during cataract surgery.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
32
|
|
Overall Study
Other
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
4
|
|
Overall Study
Death
|
0
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
8
|
Baseline Characteristics
Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs
Baseline characteristics by cohort
| Measure |
Cohort 1
n=453 Participants
ACRYSOF IQ RESTOR Multifocal Toric IOL (+3.0 D or +2.5 D) implanted in at least one eye during cataract surgery.
|
Cohort 2
n=1792 Participants
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in at least one eye during cataract surgery.
|
Total
n=2245 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Less that 65 years
|
148 participants
n=5 Participants
|
432 participants
n=7 Participants
|
580 participants
n=5 Participants
|
|
Age, Customized
Equal to or greater than 65 years
|
305 participants
n=5 Participants
|
1360 participants
n=7 Participants
|
1665 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
274 Participants
n=5 Participants
|
1150 Participants
n=7 Participants
|
1424 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
179 Participants
n=5 Participants
|
642 Participants
n=7 Participants
|
821 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
336 participants
n=5 Participants
|
1387 participants
n=7 Participants
|
1723 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
28 participants
n=5 Participants
|
266 participants
n=7 Participants
|
294 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
14 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
83 participants
n=5 Participants
|
88 participants
n=7 Participants
|
171 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=5 Participants
|
29 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.Population: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
Post-surgical intraocular inflammation was defined as exacerbated intraocular inflammation within 180 days after IOL implantation, indicated by greater than or equal to 3+ aqueous cell within the first 14 days post-operative, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-operative, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Outcome measures
| Measure |
First Eye
n=1792 eyes
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in first eye during cataract surgery.
|
Second Eye
n=1565 eyes
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in second eye during cataract surgery.
|
|---|---|---|
|
Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2
|
5.6 event rate per 1000 implants
|
4.5 event rate per 1000 implants
|
PRIMARY outcome
Timeframe: Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.Population: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
Post-surgical intraocular inflammation was defined as exacerbated intraocular inflammation within 180 days after IOL implantation, indicated by greater than or equal to 3+ aqueous cell within the first 14 days post-operative, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-operative, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Outcome measures
| Measure |
First Eye
n=3357 eyes
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in first eye during cataract surgery.
|
Second Eye
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in second eye during cataract surgery.
|
|---|---|---|
|
Rate of Eyes With Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2
|
5.1 event rate per 1000 implants
Interval 2.95 to 8.1
|
—
|
SECONDARY outcome
Timeframe: Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye.Population: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
TASS was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 3+ aqueous cell, non-infectious etiology, and rapid onset (up to and including 2 days post-operatively). The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Outcome measures
| Measure |
First Eye
n=1792 eyes
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in first eye during cataract surgery.
|
Second Eye
n=1565 eyes
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in second eye during cataract surgery.
|
|---|---|---|
|
Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - By Eye - Cohort 2
|
1.1 event rate per 1000 implants
|
0.0 event rate per 1000 implants
|
SECONDARY outcome
Timeframe: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the firstPopulation: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
TASS was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 3+ aqueous cell, non-infectious etiology, and rapid onset (up to and including 2 days post-operatively). The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Outcome measures
| Measure |
First Eye
n=3357 eyes
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in first eye during cataract surgery.
|
Second Eye
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in second eye during cataract surgery.
|
|---|---|---|
|
Rate of Eyes With Toxic Anterior Segment Syndrome (TASS) - Overall Eyes - Cohort 2
|
0.6 event rate per 1000 implants
Interval 0.07 to 2.15
|
—
|
SECONDARY outcome
Timeframe: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the firstPopulation: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
Acute postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater or equal to 3+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous and/or vitreous abscess, and rapid onset (3 to 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Outcome measures
| Measure |
First Eye
n=1792 eyes
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in first eye during cataract surgery.
|
Second Eye
n=1565 eyes
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in second eye during cataract surgery.
|
|---|---|---|
|
Rate of Eyes With Acute Postoperative Endophthalmitis - By Eye - Cohort 2
|
0.0 event rate per 1000 implants
|
0.6 event rate per 1000 implants
|
SECONDARY outcome
Timeframe: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the firstPopulation: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
Acute postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater or equal to 3+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous and/or vitreous abscess, and rapid onset (3 to 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Outcome measures
| Measure |
First Eye
n=3357 eyes
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in first eye during cataract surgery.
|
Second Eye
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in second eye during cataract surgery.
|
|---|---|---|
|
Rate of Eyes With Acute Postoperative Endophthalmitis - Overall Eyes - Cohort 2
|
0.3 event rate per 1000 implants
Interval 0.01 to 1.66
|
—
|
SECONDARY outcome
Timeframe: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the firstPopulation: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
Chronic postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 1+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous, and delayed onset (greater than 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Outcome measures
| Measure |
First Eye
n=1792 eyes
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in first eye during cataract surgery.
|
Second Eye
n=1565 eyes
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in second eye during cataract surgery.
|
|---|---|---|
|
Rate of Eyes With Chronic Postoperative Endophthalmitis - By Eye - Cohort 2
|
0.0 event rate per 1000 implants
|
0.0 event rate per 1000 implants
|
SECONDARY outcome
Timeframe: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the firstPopulation: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
Chronic postoperative endophthalmitis was defined as exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings: Greater than or equal to 1+ aqueous cell, etiology (infectious per positive culture of ocular media; non-infectious per negative culture of ocular media), inflammatory cells in the vitreous, and delayed onset (greater than 14 days post-operatively). The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Outcome measures
| Measure |
First Eye
n=3357 eyes
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in first eye during cataract surgery.
|
Second Eye
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in second eye during cataract surgery.
|
|---|---|---|
|
Rate of Eyes With Chronic Postoperative Endophthalmitis - Overall Eyes - Cohort 2
|
0.0 event rate per 1000 implants
Interval 0.0 to 1.1
|
—
|
SECONDARY outcome
Timeframe: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the firstPopulation: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
Uncategorized post-surgical intraocular inflammation was defined as signs of exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings that do not fall in the given category of TASS, Acute Postoperative Endophthalmitis, or Chronic Postoperative Endophthalmitis: Greater than or equal to 3+ aqueous cell within the first 14 days post-op, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-op, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Outcome measures
| Measure |
First Eye
n=1792 eyes
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in first eye during cataract surgery.
|
Second Eye
n=1565 eyes
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in second eye during cataract surgery.
|
|---|---|---|
|
Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - By Eye - Cohort 2
|
4.5 event rate per 1000 implants
|
3.8 event rate per 1000 implants
|
SECONDARY outcome
Timeframe: Day 90 to 180 post second eye implantation, with the second implantation occurring up to 20 days after the firstPopulation: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
Uncategorized post-surgical intraocular inflammation was defined as signs of exacerbated intraocular inflammation within 180 days after IOL implantation associated with the following findings that do not fall in the given category of TASS, Acute Postoperative Endophthalmitis, or Chronic Postoperative Endophthalmitis: Greater than or equal to 3+ aqueous cell within the first 14 days post-op, and/or greater than or equal to 2+ aqueous cell greater than 14 days and less than or equal to 60 days post-op, and/or greater than or equal to 1+ aqueous cell greater than 60 days post-operatively or later. The event rate (per 1000 IOL implants) was calculated as "Total # of reported events / Total # of implants X 1000." No formal safety hypothesis was pre-specified for this outcome measure. This outcome measure was pre-specified for Cohort 2 only.
Outcome measures
| Measure |
First Eye
n=3357 eyes
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in first eye during cataract surgery.
|
Second Eye
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL implanted in second eye during cataract surgery.
|
|---|---|---|
|
Rate of Eyes With Uncategorized Cases of Post-Surgical Intraocular Inflammation - Overall Eyes - Cohort 2
|
4.2 event rate per 1000 implants
Interval 2.28 to 6.99
|
—
|
Adverse Events
Cohort 1 Pretreatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 1 Ocular - First Eye
Serious events: 4 serious events
Other events: 71 other events
Deaths: 0 deaths
Cohort 1 Ocular - Second Eye
Serious events: 6 serious events
Other events: 31 other events
Deaths: 0 deaths
Cohort 1 Systemic
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2 Pretreatment
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2 Ocular - First Eye
Serious events: 27 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2 Ocular - Second Eye
Serious events: 17 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2 Systemic
Serious events: 28 serious events
Other events: 0 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Cohort 1 Pretreatment
n=453 participants at risk
Events reported in this group occurred prior to attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL
|
Cohort 1 Ocular - First Eye
n=453 participants at risk
Events reported in this group occurred after attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL and include ocular events in the first implanted eye
|
Cohort 1 Ocular - Second Eye
n=253 participants at risk
Events reported in this group occurred after attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL and include ocular events in the second implanted eye
|
Cohort 1 Systemic
n=453 participants at risk
Events reported in this group occurred after attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL
|
Cohort 2 Pretreatment
n=1827 participants at risk
Events reported in this group occurred prior to attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL
|
Cohort 2 Ocular - First Eye
n=1827 participants at risk
Events reported in this group occurred after attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL and include ocular events in the first implanted eye
|
Cohort 2 Ocular - Second Eye
n=1590 participants at risk
Events reported in this group occurred after attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL and include ocular events in the second implanted eye
|
Cohort 2 Systemic
n=1827 participants at risk
Events reported in this group occurred after attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.16%
3/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Eye disorders
Anterior capsule contraction
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.22%
1/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Eye disorders
Corneal infiltrates
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.06%
1/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Eye disorders
Cystoid macular oedema
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.22%
1/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.40%
1/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.16%
3/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.06%
1/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Eye disorders
Glare
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.11%
2/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.13%
2/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Eye disorders
Macular hole
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.44%
2/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.40%
1/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Eye disorders
Refraction disorder
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.11%
2/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.40%
1/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.31%
5/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Eye disorders
Retinal tear
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.40%
1/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.13%
2/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.06%
1/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Eye disorders
Vitreoretinal traction syndrome
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.40%
1/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Eye disorders
Vitreous prolapse
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
General disorders
Death
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.11%
2/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.06%
1/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
General disorders
Eye complication associated with device
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.06%
1/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Infections and infestations
COVID-19
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.11%
2/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.22%
1/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Infections and infestations
Influenza
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.22%
1/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.16%
3/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.22%
1/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.22%
1/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.40%
1/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.33%
6/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.25%
4/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Injury, poisoning and procedural complications
Posterior capsule rupture
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Investigations
Blood urine present
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.22%
1/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.16%
3/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.11%
2/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.40%
1/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Product Issues
Device dislocation
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.40%
1/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.22%
4/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.13%
2/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.22%
1/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Surgical and medical procedures
Cerebral endovascular aneurysm repair
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Surgical and medical procedures
Corneal operation
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.44%
2/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.40%
1/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.11%
2/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.22%
1/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Surgical and medical procedures
Injection
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Surgical and medical procedures
Intra-ocular injection
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.22%
1/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.06%
1/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Surgical and medical procedures
Intraocular lens repositioning
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.22%
1/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.40%
1/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.38%
7/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.25%
4/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Surgical and medical procedures
Lens extraction
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.33%
6/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.19%
3/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Surgical and medical procedures
Lung lobectomy
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Surgical and medical procedures
Mastectomy
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Surgical and medical procedures
Nephrostomy
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Surgical and medical procedures
Retinal laser coagulation
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.11%
2/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.06%
1/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Surgical and medical procedures
Retinal operation
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.40%
1/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.11%
2/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.06%
1/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Surgical and medical procedures
Retinopexy
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.13%
2/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Surgical and medical procedures
Spinal Operation
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.22%
1/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Surgical and medical procedures
Vitrectomy
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.44%
8/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.31%
5/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Vascular disorders
Hypertension
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Vascular disorders
Shock
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.05%
1/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
Other adverse events
| Measure |
Cohort 1 Pretreatment
n=453 participants at risk
Events reported in this group occurred prior to attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL
|
Cohort 1 Ocular - First Eye
n=453 participants at risk
Events reported in this group occurred after attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL and include ocular events in the first implanted eye
|
Cohort 1 Ocular - Second Eye
n=253 participants at risk
Events reported in this group occurred after attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL and include ocular events in the second implanted eye
|
Cohort 1 Systemic
n=453 participants at risk
Events reported in this group occurred after attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL
|
Cohort 2 Pretreatment
n=1827 participants at risk
Events reported in this group occurred prior to attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL
|
Cohort 2 Ocular - First Eye
n=1827 participants at risk
Events reported in this group occurred after attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL and include ocular events in the first implanted eye
|
Cohort 2 Ocular - Second Eye
n=1590 participants at risk
Events reported in this group occurred after attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL and include ocular events in the second implanted eye
|
Cohort 2 Systemic
n=1827 participants at risk
Events reported in this group occurred after attempted implantation with the ACRYSOF IQ RESTOR Multifocal IOL
|
|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Dry eye
|
0.44%
2/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
5.1%
23/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
4.3%
11/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
6.8%
31/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
5.1%
13/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
6.0%
27/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
4.3%
11/253 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/453 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1590 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
0.00%
0/1827 • Cohort 1 and Cohort 2: Adverse events (AEs) were collected pre-treatment (Day -40 or less pre-surgery first eye) up to Day 90-180 post-surgery/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). The "At Risk" population for pretreatment and systemic AEs is reported in units of subjects. The "At Risk" population for ocular AEs is reported in units of eyes. Only total subjects/eyes affected by other non-serious AEs that occurred at greater than 5% are reported.
|
Additional Information
Sr. Clinical Project Lead, CRD Surgical
Alcon Research, LLC
Phone: 1-888-451-3937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER