Trial Outcomes & Findings for Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00 (NCT NCT03280108)

NCT ID: NCT03280108

Last Updated: 2019-10-10

Results Overview

Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter 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: 250 participants
• Primary outcome timeframe: Month 6 (Day 120-180), post second eye implantation
• Results posted on: 2019-10-10

Participant Flow

Subjects were recruited from 12 investigative sites located in the United States.

Of the 250 enrolled, 7 subjects were exited as screen failures prior to attempted implantation. This reporting group includes all subjects with at least one eye implanted (243).

Participant milestones

Measure	TFNT00 AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.	SN60AT AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Overall Study STARTED	129	114
Overall Study COMPLETED	127	114
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	TFNT00 AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.	SN60AT AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00

Baseline characteristics by cohort

Measure	TFNT00 n=129 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.	SN60AT n=114 Participants AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.	Total n=243 Participants Total of all reporting groups
Age, Continuous	65.8 years STANDARD_DEVIATION 7.31 • n=5 Participants	69.0 years STANDARD_DEVIATION 6.46 • n=7 Participants	67.3 years STANDARD_DEVIATION 7.09 • n=5 Participants
Sex: Female, Male Female	85 Participants n=5 Participants	79 Participants n=7 Participants	164 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	35 Participants n=7 Participants	79 Participants n=5 Participants
Race/Ethnicity, Customized White	113 Participants n=5 Participants	96 Participants n=7 Participants	209 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	7 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 6 (Day 120-180), post second eye implantation

Population: All-Implanted Analysis Set with data available at the visit

Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.

Outcome measures

Measure	TFNT00 n=127 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.	SN60AT n=113 Participants AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m)	-0.014 logMAR Standard Error 0.0083	-0.039 logMAR Standard Error 0.0087

PRIMARY outcome

Timeframe: Month 6 (Day 120-180), post second eye implantation

Population: All-Implanted Analysis Set with data at visit

VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.

Outcome measures

Measure	TFNT00 n=127 Eyes AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.	SN60AT n=113 Participants AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm)	0.105 logMAR Standard Error 0.0119	0.529 logMAR Standard Error 0.0127

PRIMARY outcome

Timeframe: Up to Month 6 (Day 120-180), post second eye implantation

Population: This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set).

The number of SSI's related to the optical properties of the IOL was calculated from time of implantation up to Month 6. The percentage was calculated as (# of eyes with an SSI related to the optical properties of the IOL) divided by (# of eyes with attempted IOL implantation, successful or aborted after contact with the eye) times 100. SSI's could include, but were not limited to, IOL replacement, IOL explantation, IOL repositioning, refractive laser treatment, paracentesis, vitreous aspirations, iridectomy or laser iridotomy for pupillary block, wound leak repair, and retinal detachment repair. No hypothesis testing was planned for this outcome measure.

Outcome measures

Measure	TFNT00 n=129 Eyes AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.	SN60AT n=114 Eyes AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye	1 Eyes	0 Eyes

PRIMARY outcome

Timeframe: Month 6 (Day 120-180), post second eye implantation

Population: Safety Analysis Set with contrast sensitivity test

Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly (both eyes together) with the subject's best spectacle correction under photopic (well-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.

Outcome measures

Measure	TFNT00 n=127 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.	SN60AT n=111 Participants AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Mean Photopic Without Glare Binocular Distance Contrast Sensitivity 3 cpd	1.752 log units Standard Deviation 0.2080	1.733 log units Standard Deviation 0.1989
Mean Photopic Without Glare Binocular Distance Contrast Sensitivity 6 cpd	1.923 log units Standard Deviation 0.2349	1.940 log units Standard Deviation 0.2328
Mean Photopic Without Glare Binocular Distance Contrast Sensitivity 12 cpd	1.527 log units Standard Deviation 0.2793	1.558 log units Standard Deviation 0.2566
Mean Photopic Without Glare Binocular Distance Contrast Sensitivity 18 cpd	0.993 log units Standard Deviation 0.2874	1.090 log units Standard Deviation 0.2661

PRIMARY outcome

Timeframe: Month 6 (Day 120-180), post second eye implantation

Population: Safety Analysis Set with contrast sensitivity test

Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.

Outcome measures

Measure	TFNT00 n=127 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.	SN60AT n=111 Participants AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Mean Photopic With Glare Binocular Distance Contrast Sensitivity 12 cpd	1.566 log units Standard Deviation 0.2728	1.593 log units Standard Deviation 0.2659
Mean Photopic With Glare Binocular Distance Contrast Sensitivity 3 cpd	1.759 log units Standard Deviation 0.1890	1.753 log units Standard Deviation 0.1928
Mean Photopic With Glare Binocular Distance Contrast Sensitivity 6 cpd	1.897 log units Standard Deviation 0.2322	1.971 log units Standard Deviation 0.1952
Mean Photopic With Glare Binocular Distance Contrast Sensitivity 18 cpd	1.037 log units Standard Deviation 0.2762	1.121 log units Standard Deviation 0.2537

PRIMARY outcome

Timeframe: Month 6 (Day 120-180), post second eye implantation

Population: Safety Analysis Set with contrast sensitivity test

Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic (dimly-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.

Outcome measures

Measure	TFNT00 n=127 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.	SN60AT n=111 Participants AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity 1.5 cpd	1.673 log units Standard Deviation 0.2601	1.679 log units Standard Deviation 0.2190
Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity 3 cpd	1.717 log units Standard Deviation 0.2397	1.689 log units Standard Deviation 0.2177
Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity 6 cpd	1.715 log units Standard Deviation 0.2875	1.777 log units Standard Deviation 0.2871
Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity 12 cpd	1.211 log units Standard Deviation 0.4047	1.290 log units Standard Deviation 0.4384

PRIMARY outcome

Timeframe: Month 6 (Day 120-180), post second eye implantation

Population: Safety Analysis Set with contrast sensitivity test

Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.

Outcome measures

Measure	TFNT00 n=127 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.	SN60AT n=111 Participants AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Mean Mesopic With Glare Binocular Distance Contrast Sensitivity 1.5 cpd	1.658 log units Standard Deviation 0.2296	1.678 log units Standard Deviation 0.2091
Mean Mesopic With Glare Binocular Distance Contrast Sensitivity 12 cpd	1.129 log units Standard Deviation 0.4146	1.233 log units Standard Deviation 0.4599
Mean Mesopic With Glare Binocular Distance Contrast Sensitivity 3 cpd	1.709 log units Standard Deviation 0.2307	1.692 log units Standard Deviation 0.2089
Mean Mesopic With Glare Binocular Distance Contrast Sensitivity 6 cpd	1.691 log units Standard Deviation 0.3238	1.786 log units Standard Deviation 0.2775

SECONDARY outcome

Timeframe: Month 6 (Day 120-180), post second eye implantation

Population: All-Implanted Analysis Set with data at visit

VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 66 cm m from the eye. Monocular distance corrected visual acuity at intermediate was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.

Outcome measures

Measure	TFNT00 n=127 Eyes AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.	SN60AT n=113 Eyes AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm)	0.070 logMAR Standard Error 0.0108	0.327 logMAR Standard Error 0.0114

SECONDARY outcome

Timeframe: Month 6 (Day 120-180), post second eye implantation

Population: This analysis population includes all subjects with bilateral implantation and concordant, non-missing data.

The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, "Overall, in the past 7 days, how often did you need to wear eyeglasses to see?" The proportion of subjects who respond "Never" is reported as a percentage calculated as (# of subjects responding "Never") divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100.

Outcome measures

Measure	TFNT00 n=123 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.	SN60AT n=110 Participants AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Proportion of Subjects Who Respond "Never" to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire	80.5 percentage of subjects	8.2 percentage of subjects

SECONDARY outcome

Timeframe: Month 6 (Day 120-180), post second eye implantation

Population: This analysis population includes all subjects with bilateral implantation and non-missing data.

QUVID is a patient-reported outcomes questionnaire that collects responses about visual disturbance. Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer about how severe their worst experience was on a scale from 0-4, where 0=none and 4=severe. The percentage of subjects responding "Severe" was calculated as (# of subjects responding "Severe") divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.

Outcome measures

Measure	TFNT00 n=127 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.	SN60AT n=111 Participants AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) Starbursts	20 Participants	2 Participants
Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) Halos	16 Participants	1 Participants
Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) Glare	4 Participants	2 Participants
Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) Hazy vision	0 Participants	0 Participants
Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) Blurred vision	0 Participants	0 Participants
Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) Double vision	0 Participants	0 Participants
Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID) Dark area	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Month 6 (Day 120-180), post second eye implantation

Population: This analysis population includes all subjects with bilateral implantation and non-missing data.

Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer how much the disturbance bothered them on a scale from 0-4, where 0=not bothered at all and 4=bothered very much. The percentage of subjects with most bothersome visual disturbances was calculated as (# of subjects responding "Bothered very much") divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure.

Outcome measures

Measure	TFNT00 n=127 Participants AcrySof IQ PanOptix Multifocal IOL Model TFNT00 bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.	SN60AT n=111 Participants AcrySof Monofocal IOL Model SN60AT bilaterally implanted in the capsular bag in the posterior chamber following cataract removal.
Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID Starbursts	6 Participants	1 Participants
Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID Halos	3 Participants	1 Participants
Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID Glare	2 Participants	1 Participants
Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID Hazy vision	0 Participants	1 Participants
Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID Blurred vision	0 Participants	2 Participants
Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID Double vision	0 Participants	0 Participants
Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID Dark area	0 Participants	0 Participants

Adverse Events

Preoperative

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

TFNT00 - 1st Eye

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

TFNT00 - 2nd Eye

Serious events: 2 serious events

Other events: 24 other events

Deaths: 0 deaths

TFNT00 - Systemic

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

SN60AT - 1st Eye

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

SN60AT - 2nd Eye

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

SN60AT - Systemic

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Preoperative n=243 participants at risk All subjects in the safety analysis set prior to initiation of treatment.	TFNT00 - 1st Eye n=129 participants at risk All first study eyes implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00.	TFNT00 - 2nd Eye n=127 participants at risk All second study eyes implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00.	TFNT00 - Systemic n=129 participants at risk All subjects implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00.	SN60AT - 1st Eye n=114 participants at risk All first study eyes implanted with AcrySof Monofocal IOL Model SN60AT.	SN60AT - 2nd Eye n=111 participants at risk All second study eyes implanted with AcrySof Monofocal IOL Model SN60AT.	SN60AT - Systemic n=114 participants at risk All subjects implanted with AcrySof Monofocal IOL Model SN60AT.
Cardiac disorders Acute myocardial infarction	0.00% 0/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.78% 1/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
Eye disorders Age-related macular degeneration	0.00% 0/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.88% 1/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.90% 1/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
Eye disorders Cystoid macular oedema	0.00% 0/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.79% 1/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
Eye disorders Posterior capsule rupture	0.00% 0/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.88% 1/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
Eye disorders Vitreous prolapse	0.00% 0/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.79% 1/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
Gastrointestinal disorders Abdominal wall haematoma	0.00% 0/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.78% 1/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
Gastrointestinal disorders Ileus	0.00% 0/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.78% 1/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
Hepatobiliary disorders Cholecystitis acute	0.00% 0/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.88% 1/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
Hepatobiliary disorders Cholelithiasis	0.00% 0/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.78% 1/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.88% 1/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
Infections and infestations Diverticulitis	0.00% 0/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.78% 1/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast neoplasm	0.00% 0/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.88% 1/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
Product Issues Device dislocation	0.00% 0/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.79% 1/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.88% 1/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
Renal and urinary disorders Acute kidney injury	0.00% 0/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.88% 1/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
Surgical and medical procedures Colectomy	0.00% 0/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.78% 1/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
Surgical and medical procedures Intra-ocular injection	0.00% 0/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.78% 1/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	1.6% 2/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.78% 1/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.88% 1/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.90% 1/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
Surgical and medical procedures Intraocular lens repositioning	0.00% 0/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.79% 1/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
Surgical and medical procedures Lens extraction	0.00% 0/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.78% 1/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.88% 1/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
Surgical and medical procedures Vitrectomy	0.00% 0/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.79% 1/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
Eye disorders Retinal tear	0.00% 0/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.78% 1/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."

Other adverse events

Measure	Preoperative n=243 participants at risk All subjects in the safety analysis set prior to initiation of treatment.	TFNT00 - 1st Eye n=129 participants at risk All first study eyes implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00.	TFNT00 - 2nd Eye n=127 participants at risk All second study eyes implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00.	TFNT00 - Systemic n=129 participants at risk All subjects implanted with AcrySof IQ PanOptix Multifocal IOL Model TFNT00.	SN60AT - 1st Eye n=114 participants at risk All first study eyes implanted with AcrySof Monofocal IOL Model SN60AT.	SN60AT - 2nd Eye n=111 participants at risk All second study eyes implanted with AcrySof Monofocal IOL Model SN60AT.	SN60AT - Systemic n=114 participants at risk All subjects implanted with AcrySof Monofocal IOL Model SN60AT.
Eye disorders Posterior capsule opacification	0.00% 0/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	13.2% 17/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	15.0% 19/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	3.5% 4/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	4.5% 5/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."
Investigations Intraocular pressure increased	0.41% 1/243 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	5.4% 7/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	3.9% 5/127 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/129 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	5.3% 6/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	1.8% 2/111 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/114 • Implantation through study completion, an average of 7 months Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set). "At Risk" population for ocular AEs is included with unit of "eyes."

Additional Information

Expert Clinical Project Lead, CDMA Surgical

Alcon Research

Phone: 1-888-451-3937

Email: alcon.medinfo@alcon.com

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