Trial Outcomes & Findings for Clinical Investigation of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL) (NCT NCT01424189)
NCT ID: NCT01424189
Last Updated: 2018-06-29
Results Overview
Visual acuity (VA) was measured monocularly (each eye separately) without visual correction using a 100% contrast ETDRS (Early Treatment of Diabetic Retinopathy Study) chart positioned 4 meters (m) from the participant under well-lit conditions. +0.25 diopter (D) spherical power was applied to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
677 participants
Primary outcome timeframe
Month 12 from second eye implantation
Results posted on
2018-06-29
Participant Flow
Participants were recruited from 21 investigative sites located in the United States.
Of the 677 participants enrolled, 103 were exited prior to randomization as screen failures. This reporting population includes all participants with successful IOL implantation in at least 1 eye (574).
Participant milestones
| Measure |
ReSTOR Toric IOL
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
|
ReSTOR IOL
AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation
|
|---|---|---|
|
Overall Study
STARTED
|
386
|
188
|
|
Overall Study
COMPLETED
|
373
|
182
|
|
Overall Study
NOT COMPLETED
|
13
|
6
|
Reasons for withdrawal
| Measure |
ReSTOR Toric IOL
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
|
ReSTOR IOL
AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Subject moved
|
1
|
0
|
|
Overall Study
Death
|
3
|
1
|
Baseline Characteristics
Clinical Investigation of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)
Baseline characteristics by cohort
| Measure |
ReSTOR Toric IOL
n=386 Participants
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
|
ReSTOR IOL
n=188 Participants
AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation
|
Total
n=574 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.91 years
STANDARD_DEVIATION 9.20 • n=5 Participants
|
68.36 years
STANDARD_DEVIATION 8.13 • n=7 Participants
|
67.38 years
STANDARD_DEVIATION 8.88 • n=5 Participants
|
|
Sex: Female, Male
Female
|
240 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
376 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
146 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 12 from second eye implantationPopulation: This analysis population includes all participants with successful IOL implantation in the first implanted eye with data at visit.
Visual acuity (VA) was measured monocularly (each eye separately) without visual correction using a 100% contrast ETDRS (Early Treatment of Diabetic Retinopathy Study) chart positioned 4 meters (m) from the participant under well-lit conditions. +0.25 diopter (D) spherical power was applied to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
Outcome measures
| Measure |
ReSTOR Toric IOL
n=373 eyes
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
|
ReSTOR IOL
n=180 eyes
AcrySof® ReSTOR® Multifocal IOL Model SA60D3
|
|---|---|---|
|
Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5
|
0.126 logMAR
Standard Error 0.013
|
0.125 logMAR
Standard Error 0.015
|
PRIMARY outcome
Timeframe: Month 12 from second eye implantationPopulation: This analysis population includes all participants with successful IOL implantation in the first implanted eye with data at visit.
VA was measured monocularly without visual correction using a hand-held ETDRS chart at a fixed distance that differed by lens model implanted. The logMAR ETDRS near visual acuity chart was designed for use at 40 cm; results obtained at other distances were converted to reflect the change in apparent letter size that results from the change in distance. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
Outcome measures
| Measure |
ReSTOR Toric IOL
n=373 Participants
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
|
ReSTOR IOL
n=180 Participants
AcrySof® ReSTOR® Multifocal IOL Model SA60D3
|
|---|---|---|
|
Mean Monocular Uncorrected Near Visual Acuity (UCNVA) at Fixed Distance at Visit 5
|
0.19 logMAR
Standard Deviation 0.015
|
0.24 logMAR
Standard Deviation 0.017
|
PRIMARY outcome
Timeframe: Month 12 from second eye implantationPopulation: This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye). For participants with actual SSIs, performance testing outcomes conducted prior to the secondary intervention were carried forward to the final analysis.
The rate of actual and potential secondary surgical interventions (SSIs) related to the optical properties of the IOL was estimated. If an ocular surgical intervention was performed, it qualified as an actual SSI; however; if the participant met the protocol-specified criteria that would warrant an SSI, but didn't actually undergo the SSI, it qualified as a potential SSI. Rate is presented as percentage of participants.
Outcome measures
| Measure |
ReSTOR Toric IOL
n=386 Participants
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
|
ReSTOR IOL
n=188 Participants
AcrySof® ReSTOR® Multifocal IOL Model SA60D3
|
|---|---|---|
|
Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5
Second Implanted Eye
|
0.52 percentage of participants
|
2.13 percentage of participants
|
|
Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5
First Implanted Eye
|
1.04 percentage of participants
|
2.13 percentage of participants
|
SECONDARY outcome
Timeframe: Month 12 from second eye implantationPopulation: This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
Visual disturbances/distortions were reported by the participant on the Assessment of Photic Phenomena and Lens EffectS (APPLES) questionnaire, a Patient Reported Outcome (PRO) questionnaire intended to evaluate 10 distinct visual phenomena associated with cataract extraction and IOL implantation. The first 20 questions addressed both the frequency and severity of the phenomena using a 4-point categorical scale ranging from "never" to "always" (frequency) or "none" to "severe" (severity). The final (21st) question indicated whether the participant answered the questions based on experiences with or without glasses. The participant completed the assessment as a retrospective analysis of the previous week. Rate is presented as the percentage of participants with severity score "severe" for the visual phenomenon.
Outcome measures
| Measure |
ReSTOR Toric IOL
n=386 Participants
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
|
ReSTOR IOL
n=188 Participants
AcrySof® ReSTOR® Multifocal IOL Model SA60D3
|
|---|---|---|
|
Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5
Blurred vision
|
0.8 percentage of participants
|
0.0 percentage of participants
|
|
Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5
Color distortion
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5
Flat lines look curved
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5
Straight lines look tilted
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5
Double vision
|
0.8 percentage of participants
|
0.0 percentage of participants
|
|
Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5
Feeling sick due to visual distortion
|
0.0 percentage of participants
|
0.5 percentage of participants
|
|
Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5
Glare
|
3.5 percentage of participants
|
2.7 percentage of participants
|
|
Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5
Halos
|
7.5 percentage of participants
|
11.0 percentage of participants
|
|
Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5
Hazy vision
|
1.3 percentage of participants
|
0.5 percentage of participants
|
|
Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5
Starbursts
|
4.3 percentage of participants
|
8.8 percentage of participants
|
Adverse Events
ReSTOR Toric IOL
Serious events: 45 serious events
Other events: 48 other events
Deaths: 0 deaths
ReSTOR IOL
Serious events: 21 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ReSTOR Toric IOL
n=386 participants at risk
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
|
ReSTOR IOL
n=188 participants at risk
AcrySof® ReSTOR® Multifocal IOL Model SA60D3
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Cardiac disorders
Bradycardia
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
1.1%
2/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Age-related macular degeneration (First Implanted Eye)
|
0.00%
0/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Cystoid macular oedema (First Implanted Eye)
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Cystoid macular oedema (Second Implanted Eye)
|
0.78%
3/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Eye disorder (First Implanted Eye)
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Eye disorder (Second Implanted Eye)
|
0.78%
3/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Glare (First Implanted Eye)
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Glare (Second Implanted Eye)
|
0.26%
1/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Halo vision (First Implanted Eye)
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Halo vision (Second Implanted Eye)
|
0.26%
1/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
1.1%
2/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Iris atrophy (First Implanted Eye)
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Iris atrophy (Second Implanted Eye)
|
0.26%
1/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Macular hole (Second Implanted Eye)
|
0.26%
1/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Macular oedema (Second Implanted Eye)
|
0.00%
0/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Photopsia (First Implanted Eye)
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Photopsia (Second Implanted Eye)
|
0.26%
1/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Retinal detachment (First Implanted Eye)
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Retinal detachment (Second Implanted Eye)
|
0.52%
2/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Retinal tear (Second Implanted Eye)
|
0.26%
1/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Vision blurred (First Implanted Eye)
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Vision blurred (Second Implanted Eye)
|
0.00%
0/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Visual impairment (First Implanted Eye)
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Visual impairment (Second Implanted Eye)
|
0.26%
1/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Vitreous prolapse (First Implanted Eye)
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Gastrointestinal disorders
Colitis
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.52%
2/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
General disorders
Death
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
General disorders
Device dislocation (First Implanted Eye)
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Infections and infestations
Gastroenteritis viral
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Infections and infestations
Pyothorax
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Infections and infestations
Sepsis
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Injury, poisoning and procedural complications
Cataract operation complication (First Implanted Eye)
|
0.52%
2/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Injury, poisoning and procedural complications
Cataract operation complication (Second Implanted Eye)
|
0.26%
1/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Injury, poisoning and procedural complications
Eye injury (Second Implanted Eye)
|
0.26%
1/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Injury, poisoning and procedural complications
Surgical procedure repeated (First Implanted Eye)
|
0.78%
3/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
1.1%
2/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Injury, poisoning and procedural complications
Surgical procedure repeated (Second Implanted Eye)
|
0.26%
1/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
1.6%
3/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Injury, poisoning and procedural complications
Wound complication (Second Implanted Eye)
|
0.26%
1/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Metabolism and nutrition disorders
Dehydration
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage III
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Nervous system disorders
Dementia
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Nervous system disorders
Transient ischaemic attack
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Psychiatric disorders
Mental status changes
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Renal and urinary disorders
Renal failure acute
|
0.52%
2/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiogenic pulmonary oedema
|
0.00%
0/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Surgical and medical procedures
Corneal operation (First Implanted Eye)
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Surgical and medical procedures
Corneal operation (Second Implanted Eye)
|
0.26%
1/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Surgical and medical procedures
Eye laser surgery (First Implanted Eye)
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Surgical and medical procedures
Eye laser surgery (Second Implanted Eye)
|
0.78%
3/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Surgical and medical procedures
Intraocular injection (First Implanted Eye)
|
0.00%
0/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Surgical and medical procedures
Intraocular lens repositioning (First Implanted Eye)
|
1.0%
4/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Surgical and medical procedures
Keratometry (First Implanted Eye)
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Surgical and medical procedures
Keratomileusis (First Implanted Eye)
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Surgical and medical procedures
Keratomileusis (Second Implanted Eye) A
|
0.26%
1/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Surgical and medical procedures
Retinal operation (Second Implanted Eye)
|
0.26%
1/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Surgical and medical procedures
Retinopexy (First Implanted Eye)
|
0.52%
2/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Surgical and medical procedures
Retinopexy (Second Implanted Eye)
|
0.78%
3/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Surgical and medical procedures
Rotator cuff repair
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Surgical and medical procedures
Suture insertion (Second Implanted Eye)
|
0.26%
1/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Surgical and medical procedures
Vitrectomy (First Implanted Eye)
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Vascular disorders
Aortic stenosis
|
0.26%
1/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.00%
0/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
0.53%
1/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
Other adverse events
| Measure |
ReSTOR Toric IOL
n=386 participants at risk
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
|
ReSTOR IOL
n=188 participants at risk
AcrySof® ReSTOR® Multifocal IOL Model SA60D3
|
|---|---|---|
|
Eye disorders
Dry Eye (Second Implanted Eye)
|
2.1%
8/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
5.3%
10/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Posterior capsule opacification (First Implanted Eye)
|
9.1%
35/386 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
9.0%
17/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
|
Eye disorders
Posterior capsule opacification (Second Implanted Eye)
|
8.4%
32/383 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
10.1%
19/188 • This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
|
Additional Information
Expert Clinical Project Lead, GCRA, Surgical
Alcon Research, Ltd.
Phone: 1-888-451-3937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER