Trial Outcomes & Findings for A Clinical Study of the ACRYSOF® IQ Extended Depth of Focus Intraocular Lens (IOL) (NCT NCT03274986)
NCT ID: NCT03274986
Last Updated: 2020-04-07
Results Overview
Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction adjusted for optical infinity, electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 66 cm from the spectacle plane. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
242 participants
Primary outcome timeframe
Month 6 (120-180 days post second eye implantation)
Results posted on
2020-04-07
Participant Flow
Subjects were recruited from 11 investigative sites located in the United States.
21 subjects discontinued prior to randomization, and 1 subject discontinued after randomization but prior to attempted implantation. This reporting group includes all subjects with attempted implantation, as treated. Note: 1 subject randomized to DFT015 was implanted with SN60WF. Subject withdrew at the 1 month visit.
Participant milestones
| Measure |
DFT015
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
|
SN60WF
ACRYSOF® IQ Monofocal IOL, bilateral implantation
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
113
|
|
Overall Study
Successful Implantation, as Treated
|
107
|
113
|
|
Overall Study
COMPLETED
|
107
|
111
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
DFT015
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
|
SN60WF
ACRYSOF® IQ Monofocal IOL, bilateral implantation
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
A Clinical Study of the ACRYSOF® IQ Extended Depth of Focus Intraocular Lens (IOL)
Baseline characteristics by cohort
| Measure |
DFT015
n=107 Participants
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
|
SN60WF
n=113 Participants
ACRYSOF® IQ Monofocal IOL, bilateral implantation
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.8 years
STANDARD_DEVIATION 7.82 • n=5 Participants
|
68.8 years
STANDARD_DEVIATION 6.63 • n=7 Participants
|
68.8 years
STANDARD_DEVIATION 7.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
105 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 6 (120-180 days post second eye implantation)Population: All-Implanted Analysis Set, as treated
Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction adjusted for optical infinity, electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 66 cm from the spectacle plane. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
Outcome measures
| Measure |
DFT015
n=107 Eyes
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
|
SN60WF
n=111 Eyes
ACRYSOF® IQ Monofocal IOL, bilateral implantation
|
|---|---|---|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane
|
0.148 logMAR
Standard Error 0.0120
|
0.312 logMAR
Standard Error 0.0118
|
PRIMARY outcome
Timeframe: Month 6 (120-180 days post second eye implantation)Population: All-Implanted Analysis Set, as treated
VA was tested monocularly under photopic conditions using the correction obtained from the best correction and no optical infinity adjustment, electronic ETDRS charts at a distance of 4 m from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
Outcome measures
| Measure |
DFT015
n=107 Eyes
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
|
SN60WF
n=111 Eyes
ACRYSOF® IQ Monofocal IOL, bilateral implantation
|
|---|---|---|
|
Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) logMAR [(4 Meters (m)] From Spectacle Plane
|
0.016 logMAR
Standard Error 0.0091
|
-0.036 logMAR
Standard Error 0.0089
|
PRIMARY outcome
Timeframe: Month 6 (120-180 days post second eye implantation)Population: All-Implanted Analysis Set, as treated. Number analyzed is the number of subjects/eyes with data available for analysis at specified defocus.
Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction and added defocus. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified for the first operative eye. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
DFT015
n=107 Eyes
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
|
SN60WF
n=111 Eyes
ACRYSOF® IQ Monofocal IOL, bilateral implantation
|
|---|---|---|
|
Monocular Depth of Focus (Measured in the Negative Direction From 0) at 0.20 logMAR From the Mean Defocus Curve
|
1.53 diopter
|
0.99 diopter
|
PRIMARY outcome
Timeframe: Month 6 (120-180 days post second eye implantation)Population: All-Implanted Analysis Set, as treated.
VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS charts at a distance of 66 cm from the eye. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
DFT015
n=107 Eyes
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
|
SN60WF
n=111 Eyes
ACRYSOF® IQ Monofocal IOL, bilateral implantation
|
|---|---|---|
|
Percentage of Eyes Achieving Monocular Photopic DCIVA 0.20 logMAR or Better
|
72.9 percentage of eyes
|
25.2 percentage of eyes
|
PRIMARY outcome
Timeframe: Day 0 (first operative eye visit), up to Month 6 (120-180 days post second eye implantation)Population: This analysis population included all eyes with attempted IOL implantation (successful or aborted after contact with the eye) (Safety Analysis Set).
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular AEs are events localized to the eye. Cumulative and persistent serious adverse events as defined in ISO 11979-7:2014 were collected. This outcome measure was prespecified for the Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
DFT015
n=107 Eyes
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
|
SN60WF
n=106 Eyes
ACRYSOF® IQ Monofocal IOL, bilateral implantation
|
|---|---|---|
|
Percentage of Subjects With Ocular Adverse Events
Cumulative: Cystoid macular oedema
|
0.9 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Ocular Adverse Events
Cumulative: Hypopyon
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Ocular Adverse Events
Cumulative: Endophthalmitis
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Ocular Adverse Events
Cumulative: Lens dislocated from posterior chamber
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Ocular Adverse Events
Cumulative: Pupillary block
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Ocular Adverse Events
Cumulative: Retinal detachment
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Ocular Adverse Events
Cumulative: Secondary surgical intervention
|
0.0 percentage of subjects
|
1.9 percentage of subjects
|
|
Percentage of Subjects With Ocular Adverse Events
Cumulative: Cataract operation complication
|
0.0 percentage of subjects
|
1.9 percentage of subjects
|
|
Percentage of Subjects With Ocular Adverse Events
Cumulative: Hyphaema
|
0.9 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Ocular Adverse Events
Cumulative: Transient ischaemic attack
|
0.9 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Ocular Adverse Events
Persistent: Corneal stroma oedema
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Ocular Adverse Events
Persistent: Cystoid macular oedema
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Ocular Adverse Events
Persistent: Iritis
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Ocular Adverse Events
Persistent: Raised IOP requiring treatment
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
PRIMARY outcome
Timeframe: Month 6 (120-180 days post second eye implantation)Population: Safety Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at without glare and with glare assessments.
Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed monocularly with the subject's best spectacle correction under mesopic (low, but not quite dark) conditions at a distance of 8 (2.45 m) feet from the eye at a spatial frequency of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT with and without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. A higher numeric value represented better contrast sensitivity. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
DFT015
n=107 Eyes
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
|
SN60WF
n=113 Eyes
ACRYSOF® IQ Monofocal IOL, bilateral implantation
|
|---|---|---|
|
Mesopic Contrast Sensitivity
12 cpd With Glare
|
0.817 log unit
Standard Deviation 0.3494
|
0.999 log unit
Standard Deviation 0.4020
|
|
Mesopic Contrast Sensitivity
1.5 cpd Without Glare
|
1.506 log unit
Standard Deviation 0.2560
|
1.498 log unit
Standard Deviation 0.2434
|
|
Mesopic Contrast Sensitivity
3 cpd Without Glare
|
1.447 log unit
Standard Deviation 0.3381
|
1.482 log unit
Standard Deviation 0.2829
|
|
Mesopic Contrast Sensitivity
6 cpd Without Glare
|
1.340 log unit
Standard Deviation 0.3850
|
1.548 log unit
Standard Deviation 0.3177
|
|
Mesopic Contrast Sensitivity
12 cpd Without Glare
|
0.840 log unit
Standard Deviation 0.3681
|
1.003 log unit
Standard Deviation 0.3769
|
|
Mesopic Contrast Sensitivity
1.5 cpd With Glare
|
1.504 log unit
Standard Deviation 0.2555
|
1.475 log unit
Standard Deviation 0.2569
|
|
Mesopic Contrast Sensitivity
3 cpd With Glare
|
1.458 log unit
Standard Deviation 0.3304
|
1.499 log unit
Standard Deviation 0.2838
|
|
Mesopic Contrast Sensitivity
6 cpd With Glare
|
1.364 log unit
Standard Deviation 0.3856
|
1.529 log unit
Standard Deviation 0.3256
|
SECONDARY outcome
Timeframe: Month 6 (120-180 days post second eye implantation)Population: All-Implanted Analysis Set, as treated.
VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS chart set at 40 cm from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.
Outcome measures
| Measure |
DFT015
n=107 Eyes
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
|
SN60WF
n=111 Eyes
ACRYSOF® IQ Monofocal IOL, bilateral implantation
|
|---|---|---|
|
Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) (logMAR) 40 cm From Spectacle Plane
|
0.359 logMAR
Standard Error 0.0147
|
0.515 logMAR
Standard Error 0.0144
|
SECONDARY outcome
Timeframe: Month 6 (120-180 days post second eye implantation)Population: All-Implanted Analysis Set, as treated.
The IOLSAT questionnaire assessed the subjective quality of vision with respect to need for spectacles, as well as the subject's expectation and satisfaction with their quality of vision at 6 months. Results are reported consistent with multiple testing strategy.
Outcome measures
| Measure |
DFT015
n=102 Participants
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
|
SN60WF
n=111 Participants
ACRYSOF® IQ Monofocal IOL, bilateral implantation
|
|---|---|---|
|
Percentage of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire: "Overall, in the Past 7 Days, How Often Did You Need to Wear Eyeglasses to See?"
|
21.6 percentage of subjects
|
3.6 percentage of subjects
|
SECONDARY outcome
Timeframe: Month 6 (120-180 days post second eye implantation)Population: All-Implanted Analysis Set, as treated.
VA was tested monocularly under photopic conditions with no refractive correction or adjustment for optical infinity, using electronic ETDRS charts at a distance of 66 cm from the spectacle plane. UCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
DFT015
n=107 Eyes
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
|
SN60WF
n=111 Eyes
ACRYSOF® IQ Monofocal IOL, bilateral implantation
|
|---|---|---|
|
Monocular Photopic Uncorrected Intermediate Visual Acuity (UCIVA) (logMAR) 66 cm From Spectacle Plane
|
0.136 logMAR
Standard Deviation 0.110
|
0.261 logMAR
Standard Deviation 0.147
|
SECONDARY outcome
Timeframe: Month 6 (120-180 days post second eye implantation)Population: All-Implanted Analysis Set, as treated.
VA was tested monocularly under photopic conditions without refractive correction but with adjustment for optical infinity, electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. UCDVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA.This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
DFT015
n=107 Eyes
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
|
SN60WF
n=111 Eyes
ACRYSOF® IQ Monofocal IOL, bilateral implantation
|
|---|---|---|
|
Monocular Photopic Uncorrected Distance Visual Acuity (UCDVA) (logMAR)
|
0.117 logMAR
Standard Deviation 0.122
|
0.056 logMAR
Standard Deviation 0.148
|
SECONDARY outcome
Timeframe: Month 6 (120-180 days post second eye implantation)Population: Safety Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at specified visual disturbances.
Rates of severe and most bothersome visual disturbances as reported by the subjects on the QUVID questionnaire, a Patient Reported Outcome (PRO) questionnaire. No formal statistical hypothesis testing was planned.
Outcome measures
| Measure |
DFT015
n=106 Participants
ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation
|
SN60WF
n=113 Participants
ACRYSOF® IQ Monofocal IOL, bilateral implantation
|
|---|---|---|
|
Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)
Severe: Double vision
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)
Severe: Starbursts
|
3.8 percentage of subjects
|
2.7 percentage of subjects
|
|
Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)
Severe: Halos
|
0.9 percentage of subjects
|
0.9 percentage of subjects
|
|
Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)
Severe: Glare
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)
Severe: Hazy vision
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)
Severe: Blurred vision
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)
Severe: Dark area
|
0.9 percentage of subjects
|
0.9 percentage of subjects
|
|
Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)
Most Bothersome: Starbursts
|
1.9 percentage of subjects
|
0.9 percentage of subjects
|
|
Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)
Most Bothersome: Halos
|
0.9 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)
Most Bothersome: Glare
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)
Most Bothersome: Hazy vision
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)
Most Bothersome: Blurred vision
|
0.9 percentage of subjects
|
1.8 percentage of subjects
|
|
Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)
Most Bothersome: Double vision
|
0.0 percentage of subjects
|
0.0 percentage of subjects
|
|
Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)
Most Bothersome: Dark area
|
0.9 percentage of subjects
|
0.9 percentage of subjects
|
Adverse Events
Preoperative
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DFT015 First Eye
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
DFT015 Second Eye
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
DFT015 Systemic
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
SN60WF First Eye
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
SN60WF Second Eye
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
SN60WF Systemic
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Preoperative
n=220 participants at risk
All subjects in the safety analysis set prior to initiation of treatment
|
DFT015 First Eye
n=107 participants at risk
All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the first implanted eye
|
DFT015 Second Eye
n=106 participants at risk
All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the second implanted eye
|
DFT015 Systemic
n=107 participants at risk
All subjects with attempted test article implantation (successful or aborted after contact with the eye)
|
SN60WF First Eye
n=113 participants at risk
All eyes with attempted control article implantation (successful or aborted after contact with the eye) in the first implanted eye
|
SN60WF Second Eye
n=113 participants at risk
All eyes with attempted control article implantation (successful or aborted after contact with the eye) in the second implanted eye
|
SN60WF Systemic
n=113 participants at risk
All subjects with attempted control article implantation (successful or aborted after contact with the eye)
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.88%
1/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Cardiac disorders
Heart valve incompetence
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.88%
1/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Eye disorders
Cystoid macular oedema
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.93%
1/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.88%
1/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.88%
1/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Eye disorders
Photopsia
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.88%
1/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.88%
1/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.93%
1/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.88%
1/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.93%
1/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.93%
1/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
1.9%
2/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Injury, poisoning and procedural complications
Bladder injury
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.93%
1/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
1.9%
2/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.88%
1/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.93%
1/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.93%
1/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Injury, poisoning and procedural complications
Surgical procedure repeated
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
1.9%
2/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.93%
1/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.93%
1/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.93%
1/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Surgical and medical procedures
Aneurysm repair
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.88%
1/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Surgical and medical procedures
Lens extraction
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.88%
1/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Surgical and medical procedures
Vitrectomy
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.88%
1/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Eye disorders
Hyphaema
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.93%
1/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.93%
1/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
Other adverse events
| Measure |
Preoperative
n=220 participants at risk
All subjects in the safety analysis set prior to initiation of treatment
|
DFT015 First Eye
n=107 participants at risk
All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the first implanted eye
|
DFT015 Second Eye
n=106 participants at risk
All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the second implanted eye
|
DFT015 Systemic
n=107 participants at risk
All subjects with attempted test article implantation (successful or aborted after contact with the eye)
|
SN60WF First Eye
n=113 participants at risk
All eyes with attempted control article implantation (successful or aborted after contact with the eye) in the first implanted eye
|
SN60WF Second Eye
n=113 participants at risk
All eyes with attempted control article implantation (successful or aborted after contact with the eye) in the second implanted eye
|
SN60WF Systemic
n=113 participants at risk
All subjects with attempted control article implantation (successful or aborted after contact with the eye)
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/220 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
4.7%
5/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
5.7%
6/106 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/107 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
8.0%
9/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
7.1%
8/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
0.00%
0/113 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
|
Additional Information
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