Trial Outcomes & Findings for Clareon Toric vs Eyhance Toric (NCT NCT05481125)

Last Updated: 2024-10-30

Results Overview

Visual acuity was tested at a distance of 4 meters using a refraction chart and the correction obtained from a manifest refraction. BCDVA was measured in logarithm minimum angle of resolution (logMAR) units, with 0.00 logMar equating to 20/20 Snellen, which is considered normal distance eyesight. A lower logMAR value (more negative value) indicates better eyesight. This was a subject based assessment, and subject assigned a single score for both eyes.

Recruitment status

COMPLETED

Study phase

Target enrollment

203 participants

Primary outcome timeframe

Month 3 postoperative visit

Results posted on

2024-10-30

Participant Flow

Subjects were recruited from 8 investigative sites located in the United States.

Of the 203 enrolled, 14 subjects were exited prior to randomization as screen failures, and 14 subjects were discontinued after randomization and prior to attempted implantation. This reporting group includes all subjects with attempted implantation per actual treatment (175).

Participant milestones

Participant milestones
Measure	Clareon/Clareon Toric Phacoemulsification surgery, followed by implantation with Alcon Clareon Aspheric Hydrophobic Acrylic IOL or Alcon Clareon Aspheric Hydrophobic Acrylic Toric IOL, as indicated. The second eye surgery was recommended to occur within 14 days after the 1st eye surgery.	Eyhance/Eyhance Toric Phacoemulsification surgery, followed by implantation with TECNIS Eyhance IOL or TECNIS Eyhance Toric II IOL, as indicated. The second eye surgery was recommended to occur within 14 days after the 1st eye surgery.
Overall Study STARTED	89	86
Overall Study First Eye Implanted	89	86
Overall Study Second Eye Implanted	86	84
Overall Study COMPLETED	88	84
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Clareon/Clareon Toric Phacoemulsification surgery, followed by implantation with Alcon Clareon Aspheric Hydrophobic Acrylic IOL or Alcon Clareon Aspheric Hydrophobic Acrylic Toric IOL, as indicated. The second eye surgery was recommended to occur within 14 days after the 1st eye surgery.	Eyhance/Eyhance Toric Phacoemulsification surgery, followed by implantation with TECNIS Eyhance IOL or TECNIS Eyhance Toric II IOL, as indicated. The second eye surgery was recommended to occur within 14 days after the 1st eye surgery.
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Clareon Toric vs Eyhance Toric

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clareon/Clareon Toric n=89 Participants Phacoemulsification surgery, followed by implantation with Alcon Clareon Aspheric Hydrophobic Acrylic IOL or Alcon Clareon Aspheric Hydrophobic Acrylic Toric IOL, as indicated. The second eye surgery was recommended to occur within 14 days after the 1st eye surgery.	Eyhance/Eyhance Toric n=86 Participants Phacoemulsification surgery, followed by implantation with TECNIS Eyhance IOL or TECNIS Eyhance Toric II IOL, as indicated. The second eye surgery was recommended to occur within 14 days after the 1st eye surgery.	Total n=175 Participants Total of all reporting groups
Age, Continuous	69.0 years STANDARD_DEVIATION 7.63 • n=5 Participants	70.4 years STANDARD_DEVIATION 7.73 • n=7 Participants	69.7 years STANDARD_DEVIATION 7.69 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	54 Participants n=7 Participants	101 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	32 Participants n=7 Participants	74 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	77 Participants n=5 Participants	74 Participants n=7 Participants	151 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	70 Participants n=5 Participants	74 Participants n=7 Participants	144 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	15 Participants n=5 Participants	9 Participants n=7 Participants	24 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	89 participants n=5 Participants	86 participants n=7 Participants	175 participants n=5 Participants

PRIMARY outcome

Timeframe: Month 3 postoperative visit

Population: AAS with data at visit

Outcome measures

Outcome measures
Measure	Clareon/Clareon Toric n=86 Participants Phacoemulsification surgery, followed by implantation with Alcon Clareon Aspheric Hydrophobic Acrylic IOL or Alcon Clareon Aspheric Hydrophobic Acrylic Toric IOL, as indicated. The second eye surgery was recommended to occur within 14 days after the 1st eye surgery.	Eyhance/Eyhance Toric n=81 Participants Phacoemulsification surgery, followed by implantation with TECNIS Eyhance IOL or TECNIS Eyhance Toric II IOL, as indicated. The second eye surgery was recommended to occur within 14 days after the 1st eye surgery.
Mean Binocular Best-corrected Distance Visual Acuity (BCDVA) at 4 Meters Under Bright Lighting Conditions	-0.100 logMAR Standard Deviation 0.0880	-0.055 logMAR Standard Deviation 0.0716

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clareon/Clareon Toric First Eye

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Clareon/Clareon Toric Second Eye

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Clareon/Clareon Toric Systemic

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Eyhance/Eyhance Toric First Eye

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Eyhance/Eyhance Toric Second Eye

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Eyhance/Eyhance Toric Systemic

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pretreatment n=175 participants at risk All subjects in the safety analysis set prior to initiation of treatment	Clareon/Clareon Toric First Eye n=89 participants at risk All first study eyes implanted with Clareon/Clareon Toric IOL	Clareon/Clareon Toric Second Eye n=86 participants at risk All second study eyes implanted with Clareon/Clareon Toric IOL	Clareon/Clareon Toric Systemic n=89 participants at risk All subjects implanted with Clareon/Clareon Toric IOL	Eyhance/Eyhance Toric First Eye n=86 participants at risk All first study eyes implanted with Eyhance/Eyhance Toric IOL	Eyhance/Eyhance Toric Second Eye n=84 participants at risk All second study eyes implanted with Eyhance/Eyhance Toric IOL	Eyhance/Eyhance Toric Systemic n=86 participants at risk All subjects implanted with Eyhance/Eyhance Toric IOL
Eye disorders Ciliary zonular weakness	0.00% 0/175 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/89 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/89 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	1.2% 1/86 • Number of events 1 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/84 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.
Eye disorders Cystoid macular oedema	0.00% 0/175 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/89 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/89 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	1.2% 1/86 • Number of events 1 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/84 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.
Eye disorders Iris disorder	0.00% 0/175 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	1.1% 1/89 • Number of events 1 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/89 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/84 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.
General disorders Asthenia	0.00% 0/175 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/89 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	1.1% 1/89 • Number of events 1 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/84 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.
Infections and infestations Appendicitis	0.00% 0/175 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/89 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	1.1% 1/89 • Number of events 1 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/84 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.
Injury, poisoning and procedural complications Fall	0.00% 0/175 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/89 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/89 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/84 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	1.2% 1/86 • Number of events 1 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/175 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/89 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/89 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/84 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	1.2% 1/86 • Number of events 1 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.
Investigations Intraocular pressure increased	0.00% 0/175 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/89 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/89 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	1.2% 1/86 • Number of events 1 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/84 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/175 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/89 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/89 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/84 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	1.2% 1/86 • Number of events 1 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.
Product Issues Device dislocation	0.00% 0/175 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	1.1% 1/89 • Number of events 1 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/89 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/84 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.
Surgical and medical procedures Intraocular lens repositioning	0.00% 0/175 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	1.1% 1/89 • Number of events 1 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/89 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/84 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.

Other adverse events

Other adverse events
Measure	Pretreatment n=175 participants at risk All subjects in the safety analysis set prior to initiation of treatment	Clareon/Clareon Toric First Eye n=89 participants at risk All first study eyes implanted with Clareon/Clareon Toric IOL	Clareon/Clareon Toric Second Eye n=86 participants at risk All second study eyes implanted with Clareon/Clareon Toric IOL	Clareon/Clareon Toric Systemic n=89 participants at risk All subjects implanted with Clareon/Clareon Toric IOL	Eyhance/Eyhance Toric First Eye n=86 participants at risk All first study eyes implanted with Eyhance/Eyhance Toric IOL	Eyhance/Eyhance Toric Second Eye n=84 participants at risk All second study eyes implanted with Eyhance/Eyhance Toric IOL	Eyhance/Eyhance Toric Systemic n=86 participants at risk All subjects implanted with Eyhance/Eyhance Toric IOL
Eye disorders Posterior capsule opacification	0.00% 0/175 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	5.6% 5/89 • Number of events 5 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	4.7% 4/86 • Number of events 4 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/89 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	1.2% 1/86 • Number of events 1 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	1.2% 1/84 • Number of events 1 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.
Investigations Intraocular pressure increased	0.00% 0/175 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	6.7% 6/89 • Number of events 6 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	5.8% 5/86 • Number of events 5 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/89 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	5.8% 5/86 • Number of events 5 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	7.1% 6/84 • Number of events 7 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.	0.00% 0/86 • Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all eyes with attempted IOL implantation (successful or aborted after contact with the eye) as treated.

Additional Information

Director, Clinical Projects, Surgical

Alcon Research, LLC

Phone: 1-888-451-3937

Email: [email protected]

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