Clinical Investigation of the Clareon® IOL
Phase: NA
Conditions: Cataract
Sponsor: Alcon Research



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the co-primary analysis, will be conducted using the Best-Case 
Analysis Set (BAS). BAS includes all eyes successfully implanted 
with the test article that had:
at least 1 postoperative visit;
no pre-operative ocular pathology;
no macular degeneration detected at any time; and
no previous surgery for the correction of refractive errors.
The Rotation Analysis Set (RAS) will include all eyes with 
successful test article implantation from a sub-set of approximately 
6 clinical sites that examine subjects for rotational stability. The 
Safety Analysis Set will include all eyes with attempted 
implantation with the test article (successful or aborted after 
contact with the eye) and will be used for the safety analyses. 
The primary effectiveness objective is to demonstrate that the one-
sided exact 95% upper confidence limit for the percentage of 
subjects with monocular BCDVA of 0.3 logMAR or better at 12 
months postoperative (Visit 5) is greater than or equal to the SPE 
rates of 92.5% for the AAS and 96.7% for the BAS (as reported in 
EN ISO 11979-7:2014). A successful outcome on the co-primary 
effectiveness endpoints is indicated by successful outcomes on 
both of these endpoints. The number and percentage of subjects 
with BCDVA of 0.3 logMAR or better at 12months postoperative 
(Visit 5) will be presentedwith the corresponding two-sided exact 
95% confidence interval as well.
The secondary effectiveness objectives are
To demonstrate rotational stability by showing IOL rotation 
at 6 months postoperative (Visit 4) is
o less than 10° in 90% of eyes in the RAS 
o less than 20° in 95% of eyes in the RAS
o less than 30° in 99% of eyes in the RAS
To describe IOL misplacement, IOL rotation, and IOL 
misalignment
IOL rotation at Visit [x] is defined as the difference between axis 
of IOL orientation on the day of surgery and the postoperative 
Visit[x]. IOL misplacement is defined as the difference between 
intended axis of placement and actual axis of IOL orientation on 
the day of surgery. IOL misalignment at Visit [x] is defined as the 
summation of IOL misplacement and IOL misalignment at 
Visit[x].
In orderto summarize IOL rotation, IOL misplacement and IOL 
misalignment, sample size, number, percent, and cumulative 
percent for the following categories will be provided: (<10, <20, 
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and <30 degrees respectively, and 0-5, >5-10, >10-15, >15-20, 
>20-30, and >30 degrees, respectively). 
Descriptive statistics (mean, median, standard deviation, number of 
subjects/eyes, minimum, maximum, and the two-sided 95% 
confidence interval) will be provided for effectiveness endpoints 
for study eyes.
Descriptive statistics for adverse events (including SSI) will be 
presented for study eyes.The rates of all adverse events will be 
provided with counts and percentages, and these rates will be 
accompanied by two-sided exact 95% confidence intervals. The 
one-sided exact 95%lower confidence limit for incidence rates 
observed for study eyes will be compared to the cumulative and 
persistent adverse event SPE rates that include SSIs (as reported in 
EN ISO 11979-7:2014)
In general, descriptive statistics generated for effectiveness and 
safety parameters will be based upon the type of parameter (ie, 
whether the data were categorical or continuous) being analyzed. 
For categorical parameters, the statistics used to summarize the 
data descriptively included sample size, number in thecategory, 
and percent in the category. For continuous parameters, sample 
size, mean, median, standard deviation, minimum, and maximum 
will be presented. One-year follow-up analyses will be conducted 
to summarize the effectiveness and safety outcomes at Month12 
(Visit 5).
Sample Size 
Justification
With a sample size of 300 evaluable eyes, the probability to 
demonstrate that at least 270 (90%) of evaluable eyes implanted 
with Clareon IOL having monocular BCDV
A
 of 0.3 logMAR or 
better at 12 months postoperative(Visit 5) is greater than 99% 
assuming the mean BCDVA
 is 0.0 logMAR (SD = 0.18for 
All-Implanted Analysis Set). 
Similarly, with a sample size of 300 evaluable eyes, the probability 
to demonstrate that at least 285 (95%) of evaluable eyes implanted 
with Clareon IOL having monocular BCDV
A
 of 0.3 logMAR or 
better at 12 months postoperative (Visit 5) is greater than 97% 
assuming the mean BCDVA
 is 0.0 logMAR (SD = 0.16for 
Best-Case Analysis Set).
For any adverse event where zero incidence is observed in 300 
eyes with Clareon IOL, the one-sided exact 95% upper confidence 
is less than 1%. Thus, with 95% confidence, the true adverse event 
rate is less than 1%. 
Approximately 350 subjects will be unilaterally implanted with the 
Clareon IOL in order to ensure at least 300 evaluable subjects 
complete the study.
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2 TABLE OF CONTENTS
Clinical Investigation of the Clareon
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IOL.................................................................................1
1 PROTOCOL SYNOPSIS......................................................................................................2
2 TABLE OF CONTENTS.......................................................................................................6
List of Tables................................................................................................................................9
List of Figures..............................................................................................................................9
3 ABBREVIATIONS.............................................................................................................10
4 GLOSSARY OF TERMS....................................................................................................12
5 AMENDMENTS.................................................................................................................14
6 SCHEDULE OF VISITS.....................................................................................................15
7 INTRODUCTION...............................................................................................................17
7.1
Background......................................................................................................................17
7.2
Clinical Trial Design........................................................................................................17
8 CLINICAL TRIAL
 OBJECTIVES......................................................................................19
8.1
Primary Effectiveness Objective.....................................................................................19
8.1.1
Co-Primary Effectiveness Endpoints...........................................................................19
8.2
Secondary Effectiveness Objectives................................................................................19
8.2.1
Secondary Effectiveness Endpoints.............................................................................19
8.3
Primary Safety Objective................................................................................................19
8.3.1
Primary Safety Endpoint.............................................................................................19
9 INVESTIGATIONAL PLAN..............................................................................................21
9.1
Study Design...................................................................................................................21
9.2
Rationale for Study Design.............................................................................................21
9.3
Sub-study to 
Assess Rotational Stability of the Clareon IOL.........................................22
9.4
Risk Benefit Assessment.................................................................................................22

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9.5
Known and Potential Risks.............................................................................................22
9.6
Potential Benefits.............................................................................................................23
10SUBJECT POPULATION...................................................................................................24
10.1 Inclusion Criteria.............................................................................................................24
10.2 Exclusion Criteria............................................................................................................25
10.3 Reasons for Discontinuation During Surgery..................................................................26
11TREATMENT......................................................................................................................27
11.1 Investigational Product....................................................................................................27
11.2Usage...............................................................................................................................29
11.3Accountability Procedures...............................................................................................30
12CLINICAL TRIAL
 PROCEDURES...................................................................................32
12.1 Clinical Trial Assessments...............................................................................................32
12.2 Prescreening....................................................................................................................32
12.3 Prohibited Procedures......................................................................................................32
12.4 Preoperative Visit (Visit 0)..............................................................................................32
12.5 Operative Visit (Visit 00).................................................................................................34
12.6 1-Day PostoperativeVisit (Visit 1)..................................................................................34
12.7 1-Week Postoperative Visit (Visit 2)...............................................................................35
12.8 1-Month Postoperative Visit (Visit 3)..............................................................................36
12.9 4-6 Month Postoperative Visit (Visit 4)...........................................................................37
12.101-Year Postoperative Visit (Visit 5/ Early Exit Visit)......................................................38
12.11Unscheduled Visits..........................................................................................................38
12.12Discontinued Subjects.....................................................................................................39
12.13Missed Visit.....................................................................................................................40
12.14Subject Lost to Follow-up...............................................................................................40
12.15Clinical Trial Termination...............................................................................................40
12.16Aborted Implantation.......................................................................................................41
 
ADVERSE EVENTS......................................................42
13.1 General Information........................................................................................................42
13.2 Serious Adverse Events (SAEs)......................................................................................43
13.2.1 Cumulative Serious Adverse Events...........................................................................44
13.2.2 Persistent Serious Adverse Events...............................................................................44

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13.3 Supportive Characterization of Ocular Adverse Events..................................................45
13.4 Secondary Surgical Interventions (SSI)..........................................................................45
13.6 Monitoring for Adverse Events.......................................................................................45
13.7 Procedures for Recording and Reporting........................................................................46
13.7.1 Intensity and Causality Assessments...........................................................................47
13.7.1.1 Causality..................................................................................................................47
13.7.1.2 Intensity (Severity)..................................................................................................48
13.8 Unmasking of the Study Information..............................................................................48
13.9 Return Product Analysis..................................................................................................48
13.10Follow-Up of Safety Information....................................................................................48
13.11Pregnancy in the Clinical Study......................................................................................49
14DATA
 REVIEW AND HANDLING...................................................................................49
14.1 Subject Confidentiality....................................................................................................49
14.2 Completion of Source Documents and Case Report Forms............................................50
14.3 Data Review and Clarifications.......................................................................................51
14.4 Quality Assurance and Quality Control...........................................................................52
15ANALYSIS PLAN..............................................................................................................53
15.1 Subject Evaluability.........................................................................................................53
15.2 Analysis Data Sets...........................................................................................................53
15.3 Demographics and Baseline Characteristics...................................................................53
15.4 Performance Analyses.....................................................................................................53
15.4.1 Primary Performance...................................................................................................53
15.4.1.1 Statistical Hypotheses..............................................................................................54
15.4.1.2 Analysis Methods....................................................................................................54
15.4.2 Secondary Performance...............................................................................................55
15.4.2.1 Statistical Hypotheses..............................................................................................55
15.4.2.2 Analysis Methods....................................................................................................55
15.5 Handling of Missing Data...............................................................................................56
15.6 Multiplicity......................................................................................................................56
15.7 Safety Analysis................................................................................................................56

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3 ABBREVIATIONS
Abbreviation
Definition
AAS
All-Implanted Analysis Set
ADE
Adverse device effect
AE
Adverse event
ASADE
Anticipated serious adverse device effect
BAS
Best-Case Analysis Set
BCDVA
Best corrected distance visual acuity
BSS
Balanced salt solution
CFR
Code of Federal Regulations
CM
Clinical manager
CRF
Case report form
CSM
Clinical site manager
D
Diopter
DFE
Dilated fundus examination
DFU
Directions for use
DoH
Declaration of Helsinki
eCRF
Electronic case report form
EDC
Electronic data capture
ETDRS
Early Treatment Diabetic Retinopathy Study
EN
European Standard
EU
European Union
FA
Fluorescein angiography
FDA
Food and Drug Administration
GCP
Good Clinical Practice
GPCMS
Global Product ComplaintSystem
IB
Investigator’s brochure
ICF
Informed consent form
ICH
International Council forHarmonisationof Technical Requirements for 
Pharmaceuticals for Humans Use
IDE
Investigational Device Exemption
IEC
Independent ethics committee
IOL
Intraocular lens
IOP
Intraocular pressure
IRB
Independent review board
IP
Investigational product
ISO
International Organization for Standardization
LASIK
Laser-assisted in-situ keratomileusis 
LCSM
Lead clinical site manager
logMAR
Logarithm of minimum angle of resolution
MedDRA®
Medical Dictionary for Regulatory Activities
m
Meter
mm
Millimeter
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Abbreviation
Definition
MOP
Manual of procedures
N/A
Not applicable
Nd:YAG
Neodymium-doped yttrium aluminium garnet
OCT
Optical coherence tomography
OD
Right eye
OS
Left eye
OVD
Ophthalmic viscosurgical device
RAS
Rotation Analysis Set
RD
Retinal detachment
SADE
Serious adverse device effect
SAE
Serious adverse event
SOP
Standard operating procedure
SPE
Safety and Performance Endpoints
SSI
Secondary surgical intervention
USADE
Unanticipated serious adverse device effect
USV
Unscheduled visit
US
United States
UV
Ultraviolet
WHO
World Health Organization
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a) A
 life-threatening illness or injury
.
Note:Life-threatening means that the individual was at 
immediate risk of death from the event as it occurred, ie, it 
does not include an event which hypothetically might have 
caused death had it occurred in a more severe form.
b) Permanent impairment to a body structure or a body function.
c) Inpatient hospitalization or prolonged hospitalization.
Note:Planned hospitalization for a pre-existing condition, or a 
procedure required by the clinical investigation plan, without 
serious deterioration in health, is not considered a serious 
adverse event. In general, hospitalization signifies that the 
individual remained at the hospital or emergency ward for 
observation and/or treatment (usually involving an overnight 
stay) that would not have been appropriate in the physician's 
office or an outpatient setting. Complications that occur during 
hospitalization are AEs. If a complication prolongs 
hospitalization or fulfills any other serious criteria, the event is 
serious. When in doubt as to whether “hospitalization” 
occurred, the event should be considered serious.
d) a medical or surgical intervention to prevent a) or b).
Any indirect harm as a consequence of incorrect diagnostic test 
results when used within manufacturer
's instructions for use.
Fetal distress, fetal death, or a congenital abnormality or birth 
defect.
Subject Number
A
 number assigned to each subject who enrolls in the study. When 
combined with the site number, a unique identifier is created for each 
subject in the study.
Unanticipated 
Serious Adverse 
Device Effect 
(USADE)
Serious adverse device effect which by its nature, incidence, severity 
or outcome has not been identified in the risk analysis.
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5 AMENDMENTS
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Modification of the protocol is prohibited without prior written agreement in the form of a 
protocol amendment. All amendments will be created by the Sponsor and must be approved by 
the IRB/IEC prior to implementation except when required to mitigate immediate safety risks 
or when the changes involve only logistical or administrative revisions.
 
 
 
 
 
 
 
 

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7 INTRODUCTION
7.1 Background
A
 summary of known and potential risks and benefits to humans, as identified in the literature 
or through preclinical testing and/or prior clinical evaluations, for theinvestigational product 
can be found in the Investigator’s Brochure (IB-0146) andDirections for Use (DFU)/Package 
Insert 
 
 
 
 
 
 
The Clareon IOL is a foldable monofocal IOL
 intended as an optical implant for the 
replacement of the human crystalline lens in the visual correction of aphakia in adult patients 
following cataract surgery. The lens is intended to be placed in the capsular bag in the 
posterior chamber of the eye.
7.2 Clinical Trial Design
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An overview of the study flowis depicted in Figure 7-1.

Page 18 of 74
Figure7–1
Study Flow
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8 CLINICAL TRIAL OBJECTIVES
8.1 Primary Effectiveness Objective
Theprimaryeffectiveness objective of this study is to demonstrate favorable visual acuity 
and adverse event outcomes for the ClareonIOL
 compared to historical safety and 
performance endpoint (SPE) rates,as reported in EN ISO 11979-7:2014.
8.1.1 Co-Primary Effectiveness Endpoints
Percentage of all-implanted subjects achieving BCDV
A
 of 0.3 logMAR or better at 12 
months postoperative (Visit 5)
Percentage of best-case subjects achieving BCDVA
 of 0.3 logMAR or better at 12 
months postoperative (Visit 5)
8.2 Secondary Effectiveness Objectives
To demonstrate rotational stability by showing IOL rotation at 6 months postoperative 
(Visit 4) is
o less than 10° in 90 % of eyes inthe RAS
o less than 20° in 95 % of eyes inthe RAS
o less than 30° in 99 % of eyes inthe RAS
To describe IOL
 misplacement, IOL rotation, and IOL misalignment
8.2.1 Secondary Effectiveness Endpoints
IOL
 rotation at Visit [x], defined as the difference between axis of IOL orientation on 
the day of surgery and the postoperative V
isit [x]
IOL
 misplacement, defined as the difference between intended axis of placement and 
actual axis of IOL orientation on the day of surgery
IOL
 misalignment at Visit [x], defined as the summation of IOL misplacement and 
IOL
 rotation at t Visit [x].
8.3 Primary Safety Objective
8.3.1 Primary Safety Endpoint
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Rate of adverse events (ocular and nonocular, serious and non-serious) including secondary 
surgical interventions(SSIs)

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9 INVESTIGATIONAL PLAN
9.1 Study Design
This is a prospective, multicenter, single-armsafety and performance clinicalstudy, requiring 
no masking. Thetrial will evaluatethesafety and performance of theClareon IOLin 
approximately 350 unilaterally implanted subjects. To qualify for enrollment into the trial, 
adult (≥22 years of age) subjectsmust requireroutine cataract surgery in at least one eye; 
only one eye will be implanted with the study lens. Potential subjects will be screened for 
enrollment into the trial in accordance with the entry criteria found in Section 10 SUBJECT 
POPULATION.
Note:The Investigator should follow standard of care for any visits relating to the follow-up, 
surgery, and lens choice (as applicable) of the subject’
s fellow eye. 
Subjects will attend a total of 7study visits over a period of approximately 13months. Of 
theseseven visits, one is a preoperativescreening visit (Visit 0)andone is an operativevisit 
(Visit 00). The remaining five are postoperative visits(Visits 1-5),which will occur at the 
following intervals: Visit 1 Day 1-2, Visit 2 Day 7-14, Visit 3 Day 30-45, V
isit 4 Day 120-
180, and Visit 5 Day 330-420. Visit day calculations for Visits 1-5 are based off of the day of 
surgery (V
isit 00). Unscheduled visits may be conducted if needed for medical attention. 
Refer to Figure 7-1 above for a study outline diagram.
Primaryendpoint data will be collected at the final visit (Visit 5 330-420days postoperative), 
and secondary endpoint data will be collected at V
isit 3 (30-45days postoperative) and 
Visit4 (120-180 days postoperative). The study will be considered successful if the data 
indicate a favorable outcome in relation to the SPE rates as reported in EN ISO 11979-
7:2014. Additional details, including a risk-benefit assessment can be found in the sections 
below. 
Section 12 CLINICAL TRIAL PROCEDURESoutlines the procedures and assessments to 
be conducted at each study visit. This information is presented in tabular format in Section 6 
SCHEDULE OF VISITS.
9.2 Rationalefor Study Design
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The design of this study follows recommendations as set forth in EN ISO 11979-7:2014for 
the purpose of determining the safety and performance of a posterior chamber monofocal 
IOL.

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9.3 Sub-studyto Assess Rotational Stability of the Clareon IOL
Toric axis markings will be incorporated on Clareon monofocal investigational lenses for 
evaluation of rotational stability. IOL
 rotational stability
, defined as the difference in IOL axis 
of orientationfrom the day of surgery to 6 months postoperative, will be demonstrated on at 
least 100subjects; a sub-set of approximately 6 clinical trial sites will examine subjects for 
rotational stability. Complete instructions on the procedure will be detailed in the Manual of 
Procedures. IOL
 axis of orientationwill be assessed on Visit 00 (Operative visit), Visit 1 
(Day1-2), Visit 2 (Day 7-14),Visit 3 (day30-45 postoperative) and Visit 4 (day 120-180 
postoperative) Procedures Per Study V
isit.Examination will occur underdilated conditions to 
assist in visualization of the toric axis markers.
9.4 Risk Benefit 
Assessment
For a full and comprehensive risk benefit assessment,including a summary of known and 
potential risks and benefits to humans as identifiedin the literature, through preclinical 
testing, or via prior clinical investigations, refer to the study IB (IB-0146). Abbreviated 
details are provided in Section 9.5and 9.6below. 
Based on the below outlined risks and benefits, the risk of unanticipated adverse device 
effects with use of the ClareonIOL
 is considered to be low and the benefits of receiving the 
IOL
 should outweigh the risks for subjects that qualify for implantation in this study
.
9.5 Known and Potential Risks
Known and potential risks of the Clareon IOL
 are outlined here. 
SurgicalRisk
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As with any type of intraocular surgery, there is a possibility of complications due to 
anesthesia, drug reactions, and surgical problems. The surgical procedure can exacerbate a 
pre-existing ocular condition. Possible problems during surgery include corneal endothelial 
touch, detached Descemet’s membrane, iris damage, iris prolapse, iris trauma, iris 
incarceration, zonular rupture, vitreous loss, capsulorhexis tear, capsular rupture, 
uncontrollable intraocular pressure (IOP), hyphema, and retinal damage. An IOP increase 
may occur from the surgical procedure, residual viscoelastic in the eye, or a steroid response 
to postoperative medications.

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Postoperative Risk
Potentialpostoperative adverse events include,but are not limited,to corneal stromal edema, 
cystoid macular edema, endophthalmitis, hypopyon, iritis, lens dislocation, membrane 
formation on the IOL, pupillary block, retinal detachment, cyclitic membrane, transient or 
persistent glaucoma, retinal tear, vitritis, iris touch, pupil ovalization, posterior synechiae, 
ocular inflammation, ocular discomfort or pain, inflammation, decreased vision, decreased 
contrast sensitivity, decreased color perception, visual disturbances, and corneal endothelial 
cell loss.
An IOLreplacement or explantation maybe appropriate in some cases of significant residual 
refractive error, ocular infection, subject dissatisfaction, or visual disturbances (eg, glare, 
halos, starbursts, hazyvision, blurred vision, double vision, visual distortions, and color 
distortions). In most/majority of cases, spectacles or contact lensesmaybe prescribed to 
resolve residual refractive error. Othersecondarysurgical interventions include, but are not 
limited to:IOL
 repositioning, refractive lasertreatment, paracentesis, vitreous aspirations, 
and iridectomyor laser iridotomyfor pupillaryblock, wound leak repair, and retinal 
detachment repair
.
Unknown Risk
There may also be unknown risks with the use of the Clareon IOL. Any foreseen risk to 
subjects in this clinical study will be minimized by compliance with the eligibility criteria, 
study procedures, and clinical monitoring.
9.6 Potential Benefits
Known and potential benefits ofthe ClareonIOL
 are outlined here.
Cataract surgerywith IOL lens implantationbenefits patients by restoringsight
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the result of 
replacingthe natural cataractous lens with an IOL. IOL implantation may also improve color 
vision, enhance image sharpness, and decrease nighttime photic phenomena(eg, glare,halo). 
This enhancement of vision may increase overall lifestyle satisfaction (eg, more 
independence, participation in social and/or sporting activities).The Clareon IOL is expected 
to have benefits comparable to other available monofocal IOLs.
This clinical trial may benefit the medical community and future cataract patients via 
contribution to the available scientific literatureand the potential availability of an IOL with a
new lens material.

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10SUBJECT POPULATION
The study population includes approximately 350 implanted subjects enrolled at
approximately 17 investigative sites. Each Investigatorwill implantapproximately 
20subjects with no Investigatorimplantingmore than 20% of the total study population. Site 
enrollment will monitored closelyby the Sponsorto ensure surgeons have the opportunity to 
enroll 20 subjects each in order to achieve an even distribution across all sites. Each site will 
use only 1 implanting surgeon.
To participate in the clinical trial, subjects must be an adult(age 22 years or older at time of 
surgery)requiring routine cataract surgery in at least one qualifying eye. A
 full list of entry 
criteriais provided in Sections 10.1 to 10.3 below.The Investigator may also refer to the lens 
DFUor IB for further guidance, and may exclude potential subjects based upon his/her 
medical judgement. 
Each subject will contribute 1 eyeto the study. In the eventthat botheyes meet entry criteria, 
the Investigatorwill identify the study eye based on his/her medical judgement.In the event 
neither eye qualifies, the subject may notbe rescreened at a later date for qualification into 
the study
. 
Note:For study qualification, the eye identified as the study eye must meet all ocular 
inclusion/exclusion criteria. The fellow eye is exempt from meeting these criteria.
10.1Inclusion Criteria
Listed below are criteria that must be met for inclusion into the study. 
1. Adults, 22 years of age or older at the time of surgery, of either gender or any race, 
diagnosed with cataract
2. Planned routine cataract surgery (need determined by the expert opinion of the 
Investigator)
3. Calculated lens power is within the available range 
 
4. Able to comprehend and willing to sign a statement of informed consent and 
complete all required postoperative visits
5. Clear intraocular media other than cataract
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6.
 
10.2Exclusion Criteria
Listed below are criteria that exclude entry into the study
. 
1. Any disease or pathology
, other than cataract, that (in the expert opinion of the 
Investigator) is expected to reduce the potential postoperative BCDVA
 to a level 
worse than 0.30 logMAR(including, but not limited to the following: amblyopia, 
clinically severe corneal dystrophy (eg, epithelial, stromal, or endothelial 
dystrophy), diabetic retinopathy, extremely shallow anterior chamber, not due to 
swollen cataract, microphthalmos, previous retinal detachment, previous corneal 
transplant, recurrent severe anterior or posterior segment inflammation of unknown 
etiology, iris neovascularization, uncontrolled glaucoma, aniridia, optic nerve 
atrophy, clinically significant macular degeneration, or diagnosis of 
pseudoexfoliation)
2.
Previous corneal surgery
3.
Rubella or traumatic cataract
4. Ocular trauma, previous refractive surgery
, and refractive surgicalprocedures
5. Current or recent use of an alpha-1-selective adrenoceptor blocking agent or an 
antagonist of alpha1A adrenoceptor (eg,Flomax (tamsulosin HCL), Hytrin, or 
Cardura) that in the opinion of the Investigator would potentially require
mechanical or surgical manipulation to enlarge the pupil 
6.
Any other ocular or systemic comorbidity that, in the expert opinion of the 
Investigator, may confound the results of this study or prohibit the completion of 
the study assessments or increase the risk for thesubject
7.
Pregnancy, plans to become pregnant, is lactating or has other conditions associated 
with the fluctuations of hormones that could result in refractive status change
8.
Any subject currently participating in another investigational drug or device study 
that may confound the results of this investigation
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10.3Reasons for DiscontinuationDuring Surgery
Listed below are criteria that,when occurring at the time of surgery,may result in 
discontinuation fromthe study
. 
A
 subject discontinuing at the time of surgery will be not be 
considered a screen failure. In the event that a criterion listed below occurs, do not implant 
the study lens. Proceed according to the physician’s professional medical judgement for what 
is in the best interest of the subject, including, if warranted, an alternate lens. 
9. Any other additional proceduresduring the cataract removal and IOL implant due 
to intraoperative complications that require further intervention (including but not 
limited to posterior rupture, with vitreous loss, zonular dehiscence that may make 
the IOL implant less stable
10.Mechanical or surgical interventionrequired to manipulatethe pupil
11.Excessive iris mobility
12.Significant vitreous loss
13.Significant anterior chamber hyphema
14.Zonular or capsular rupture
15.Unrecognized (pre-existing but discovered during surgery) ocular conditions or 
complications in which the IOL positions could be less stable, including zonular 
weakness
16.Inability to place the IOL in the capsular bagdue to surgical complications
If the implantation was aborted and the IOL
 did nottouch the eye, then the subject is 
required to discontinue from the study and standard of care for IOL
 implantation is followed.
If the implantation was aborted and the IOL
 did
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touch the eye, then the subject is encouraged 
to attend all follow-up study visits for safety evaluation on this eye only
.SeeSection 12.16
Aborted Implantation,for additional instructions.

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Formulation
N/A
Usage
IOLs are implantable medical devices and are intended for long 
termuse over the lifetime of the pseudophakic subject.
Number/Amount of 
Product to be 
Provided to the 
Subject
Each subject will be implanted with a single test article in his/her 
study eye. 
Packaging 
description
Each IOL
 will be individually packaged and will have a unique 
serial number. The IOL
 package will contain the following items:
The IOL
A subject registration card (Lens Implant Card)
A subject identification card
Adhesive labels containing the IOL information and unique 
serial number
A package insert containing directions for use
Labeling description Packaged in a standard Alcon IOL carton. The carton is labeled with 
the following information: name of the lens, model number, overall 
diameter, optic diameter, diopter power, serial number, name of the
manufacturer, storage condition, expiration date, sterile, and single 
use. Each package is also labeled “Caution –Investigational 
device. Limited by Federal law to investigational use”.
Storage conditions
The IP must be stored in a safe, secure locationwith limited access 
separated from general stock. Transportation of product from one 
address to another must be documented and a Transportation Log 
(or similar documentation) used for appropriate accountability.
Additional 
information
In order to implantthe test article in a study subject, the surgeon 
participating in the study must be a licensed ophthalmologist with 
cataract surgery experience and trained on the protocol.
More information on the test article can be found in the IB 
(IB-0146) and product DFU (Clareon Aspheric Hydrophobic 
Acrylic IOL 
Supply
A
 designated amount of IOLs will be supplied to the site by the 
Sponsor.
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be documentedand a Transportation Log (or similar documentation) used for appropriate 
accountability.
The Investigator is to keep a current record of the inventory and dispensing of all IP. This 
record will be made available to the Sponsor’s monitor to account for allIP.
 
 
All IPsent to the 
Investigator must be accounted for and in no case should the IPbe used in any unauthorized 
situation.
 
 
 
It is the Investigator’s responsibility to return any and all unused IP to the Sponsor, as 
directed.

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12CLINICAL TRIAL PROCEDURES
12.1Clinical Trial Assessments
The following section describes in general the assessments to be performed in this clinical 
trial. Assessments aredescribed in the MOP. Refer to Section 6 SCHEDULE OF VISITS for 
an overview of assessments by visit.
All ocular assessments are required to be performed on the study eye only. Refer to 
Section10 SUBJECT POPULATION for information on study eye selection. AEs are 
collected and reported for both the study eye and fellow eye
 
12.2Prescreening
Prescreenpotential subjects. Review non-study specific inclusion/exclusion criteria (eg, age, 
cataract procedure, ocular history) to identifypotential subjectsmost likely to meetthe 
qualifications for participation in the study.Invite those prescreened candidates who may 
qualify for the study to learn more about the trial. For those interested in participation, carry 
out the informed consent process. Refer to Section 16.2 Informed Consent Procedures.
Note:Subjects must formally consent to the trial prior to any study specific testing.
12.3Prohibited Procedures
Refractive surgical procedures are prohibited in the study eye at surgery and throughout the 
duration of the subject’s participation in the clinical study. Prohibited procedures include, but 
are not limited to, LASIK, astigmatic keratotomy,and limbal relaxing incisions.
12.4PreoperativeVisit (Visit 0)
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Subjects will be considered enrolled upon consent. Each subject that signs a consent form 
must be entered into the Electronic Data Capture (EDC)system. Upon entry into the system, 
each subject will be assigned a number. This subject number will be used to identify the 
subject throughout the study. 
Below is a list of study procedures to be undertaken at Visit 0 (-30 to 0 days preoperative). 
The order of procedures is recommended. All assessments must be documented in source 
documentation and eCRFs (if applicable). NOTE: Only assessments for the study eye will be 
recorded in eCRFs, however bilateral assessments may be needed/recorded in source 
documents in the process of determining which eye should be the study eye.

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anexamination conducted by the study staff
a new finding(s), or a change to a previous finding(s) was discovered
AUSV may or may not result in the capture of an adverse event. Likewise an adverse event 
may be captured without the report of aUSV (eg, 
AE identified subsequent to study eye 
examination by non-study personnel). The assessments captured at the USV are dictated by 
the Investigator per his/her medical judgment. The following assessments are recommended.
Concomitant medications
 
Adverse events
Note:Assessments are not limited to the above list.
If the subject is discontinued at the USV, perform all Early Exit procedures. Refer to 
Section6 SCHEDULE OF VISITS. For safety purposes, if a USV is required after the final 
study visit, document the visit. Refer to Section 13.8 Follow up of Safety Information for 
further detail.
12.12Discontinued Subjects
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Discontinued subjectswithdraw, or are withdrawn from the study after signing consent, and 
prior to completing all study visits. Subjects signing consent, but withdrawing or withdrawn 
prior to surgery shall be considered discontinued due to screen failure, and the failed entry
criterion documented in source documents and in EDC. Refer to Section 10 SUBJECT 
POPULATION.
Subjects may discontinue study participation at any time and for any reason. However,it is 
incumbent upon the Investigator to carefully select subjects who understand the commitment
involved in participating in this clinical trial.

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Subjects may be discontinued from the study at any time if,in the medical opinion of the 
Principal Investigator or designated, qualified medical personnel, continued participation
poses a health risk to the subject, or other reasonable cause.
Subjects signing consent, but who voluntarily withdraw or are withdrawn by the Investigator
prior to the final study visit shall be considered discontinued of study participation.For 
subjectsdiscontinuing from the study, the Investigator should complete Exit procedures 
according to Section 12.101-YearPostoperative Visit (Visit 5/ Early Exit Visit), if the subject 
is willing and able, and if in the opinion of the Investigatorit is safe for the subject to do so. 
The reason for discontinuation must be documented in source documents and in EDC.To 
ensure the safety of all subjects who discontinue early, Investigators must assess each subject 
and, if necessary, advise them of any therapies and/or medical procedures that may be needed 
to maintain their health.
Subject numbers from discontinued subjects will not be reissued. Discontinued subjects will 
not be replaced.
12.13Missed Visit
If a subject misses a scheduled visit, reschedule the subject withinthe same visit period. 
Show diligence in trying to schedule the subject for all visits, and document all attempts to 
contact the subject in the subject’s chart. In documentation, include dates, times, method of 
contact, etc.
If a subject is unable to return for the final study visit, complete the Exit Case Report Form 
with the appropriate reason for discontinuation. If attempts to contact the subject are 
unsuccessful, document the date the subject is considered lost to follow-up. Complete the 
subject’s Exit Case Report Form after the last window closes, indicating the subject is lost to 
follow-up.
12.14Subject Lost to Follow-up
If a subject is overdue for a visit and all efforts to contact the subject for an examination have 
failed, this subject is considered lost to follow-up. The Exit Case Report Form shouldnotbe 
completed until after the subject’s lastvisitwindow closes, in case the subject is able to 
attend futurevisits. Any intermediate visits not attended will be considered Missed Visits.
12.15Clinical Trial Termination
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The Sponsor reserves the right to close aninvestigational site(s)or terminate the study in its 
entirety at any time, for reasonable cause. The Investigator also may terminate the study at 

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his/her site for reasonable cause. Reasons for the closure of an investigational site or 
termination of a study may include:
the Investigator fails to comply with the protocol or GCP guidelines
inadequate recruitment of subjects by the Investigator
subject safety concerns
If the clinical study is prematurely terminated or suspended, the Sponsor will inform the 
Investigator and the regulatory authorities of the termination/ suspension and the reason(s) 
for the termination/suspension. The Investigator should promptly notify the IRB/IECof the 
termination or suspension and of the reasons. If the Sponsor terminates the study for safety 
reasons, it will immediately notify the Investigator(s), and provide written instructions for 
study termination and applicable subject follow-up.
12.16Aborted Implantation
 
 
 Specific guidance with regards to aborted implantation is detailed 
below.
In the sections below, the IOL
 touchingthe eye is defined as the time point when any IP first 
touches the eye.
NOTE:No more than 2 attempts may be made to implant the test article.
If the second attempt to implant the test article is aborted and the IOL
 did nottouch the eye 
on either attempt, then the subject must be discontinued from the study.
If the second attempt to implant the test article is aborted and the IOL
 did touch the eye on 
either attempt, then
The eye must be followed for all study visits for a safety evaluation
The test article must NOT
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be implanted

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ADVERSE EVENTS
13.1General Information
An adverse event (AE) is any untoward medical occurrence in a subject who is administered 
a clinical trial treatment (ie, implant with an investigational device), regardless of whether or 
not the event has a causal relationship with the treatment. An AE, therefore, can be any 
unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or 
disease temporally associated with the clinical trial treatment, whether or not related to the 
treatment. Below are Figures that categorize 
AEs and SAEs.
Figure13-1
Categorization of all Adverse Events
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Figure13–2
Categorization of all Serious Adverse Events
13.2Serious Adverse Events (SAEs)
A
 serious adverse event is an AE that led to any of the following:
Death
A
 serious deterioration in the health of the subject that either resulted in:
a) a life-threatening illness or injury
NOTE: Life-threatening means that the individual was at immediate risk of death from 
the event as it occurred, ie, it does not include an event which hypothetically might 
have caused death had it occurred in a more severe form.
b) any potentially sight-threatening event or permanent impairment to a body structure 
or a body function
c) inpatient hospitalization or prolonged hospitalization
NOTE: Planned hospitalization for a pre-existing condition, without serious 
deterioration in health, is not considered a SAE. In general, hospitalization signifies 
that the individual remained at the hospital or emergency ward for observation and/or 
treatment (usually involving an overnight stay) that would not have been appropriate 
in the physician's office or an outpatient setting. Complications that occur during 
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hospitalization are AEs. If a complication prolongs hospitalization or fulfills any other 
serious criteria, the event is serious. When in doubt as to whether “hospitalization” 
occurred, the event should be considered serious.
d) a medical or surgical intervention to prevent a) or b) or any ocular secondary 
surgical intervention (excluding posterior capsulotomy [PC])
e) anyindirect harm as a consequence of incorrect diagnostic test results when used 
within manufacturer’s instructions for use
Fetal distress, fetal death, or a congenital abnormality or birth defect
Potentially sight-threatening events may also be considered serious based on the judgment of 
the Investigator and should be reported appropriately,as delineated in Section 13.7
Procedures for Recording and Reporting.
13.2.1Cumulative Serious Adverse Events
Total number of Adverse Events that have occurred at any time up to a specified timepoint 
postoperatively.
Cystoid macular edema
Hypopyon
Endophthalmitis
Lens dislocation from posterior chamber
Pupillary block
Retinal detachment
Secondary surgical intervention (excluding PC)
13.2.2Persistent Serious Adverse Events
Corneal stromal edema
Cystoid macular edema
Iritis

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Raised IOP requiring treatment
This list is consistent with the categories provided inEN ISO 11979-7:2014. 
A
 persistent AE 
is an AE that is present at the conclusion of a clinical investigation per 

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ENISO11979-7:2014. 
Any other potentially sight-threatening event may also be considered 
serious based on the judgement of the Investigator and must be reported appropriately,as 
delineated in Section 13.2. Serious Adverse Events (SAEs).
 
 
 
 
 
 
13.6Monitoring for Adverse Events
At each visit, after the subject has had the opportunity to spontaneously mention any 
problems, the Investigator should inquire about AEs by asking the standard questions such as:
“Have you had any health problems since your last study visit?”

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“Have there been any changes in the medicines you take since your last study visit?”

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Changes in any protocol-specific ocular or systemic parameter evaluated during the study are 
to be reviewed bythe Investigator. In addition, the subject’
s responses to any questionnaire 
utilized during the study are to be reviewed by the Investigator. 
Any untoward (unfavorable 
and unintended) change in a protocol-specific parameter or questionnaire response that is 
clinically relevant, in the opinion of the Investigator, is to be reported as an 
AE. These 
clinically relevant changes will be reported regardless of causality
.
13.7Procedures for Recording and Reporting
AEs are collected from the time of informed consent.Any pre-existing medical conditions or 
signs/symptoms present in a subject prior to the start of the study (ie, before ICF is signed) 
are not considered AEs in the study and should be recorded in the Medical History section of 
the eCRF
.
In addition, aqueous cells and flare, corneal edema, raised IOP and superficial punctate 
keratitis are examples of early postoperativefindings that are typically observed following 
ocular surgery. These are not considered AEs if they can be reasonably expected to resolve 
within a week and not result in any untoward long term visual outcome impact.
For each recorded event, the ADEs and SAEs documentation must include: date of 
occurrence, severity, treatment (if applicable), outcome, and assessments of the seriousness 
and causality. 
 
 The site must submit 
all available information on ADEs, SAEs, 
 to the Study Sponsor 
immediately as follows:
ADEs or SAEs are documented on the Adverse Device Effect and Serious Adverse 
Event eCRF within 24 hours of the Investigator’s or site’s awareness.
 
 
Additional relevant information after initial reporting is to be entered into the 
eCRF as soon as the data become available.
Document any changes to concomitant medications on the appropriate eCRFs.

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All relevant documentation such as Discharge Summary
, Autopsy Report, 
Certificate of Death etc, should be faxed to the Study Sponsor at 1-817-302-1927.

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USADEs must be reported to the IRB as soon as possible, but not later than10 
working days afterthe Investigator’s or site’s awareness.
NOTE: Should the EDC system become non-operational, the site must complete the
appropriate paper Adverse Device Effect and Serious Adverse Event Form 
 
The completed form is faxed to the Study Sponsor at 1-817-302-1927or 
emailed to FTW.medical_safety@alcon.comwithin 24 hours of the Investigator’s or site’
s 
awareness; however, the reported information must be entered into the EDC system once it 
becomes operational.
Any AEs 
 for non-study marketed devices/products (ie, BSS, OVD, 
delivery systems,etc) will be considered and processed as spontaneous (following the 
postmarket vigilance procedures) and should be communicated to the device’s/product’s 
manufacturer as per local requirements.
Study Sponsor representatives and their contact information are provided in the MOPthat 
accompanies this protocol.
Further, depending upon the nature of the 
AE 
 being reported, the Study 
Sponsor may request copies of applicable portions of the subject’
s medical records. The 
Investigator must also report all AEs 
 that could have led to a SADE 
according to the requirements of regulatory authorities or IRB/IEC.
13.7.1Intensity and Causality Assessments
Where appropriate, the Investigator must assess the intensity (severity) of the AE as mild, 
moderate, or severe based on medical judgment with consideration of any subjective 
symptom(s), as defined below:
13.7.1.1Causality
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For every AE in the study, the Investigator must assess the causality (Related or Not Related 
to the medical device or test procedure). An assessment of causality will also be performed 
by a Study Sponsor physician utilizing the same definitions, as shown below:
Related
An AE classified as related may be either definitely related or possibly related 
where a direct cause and effect relationship with the medical device or test 
procedure has not been demonstrated, but there is a reasonable possibility that 
the AE was caused by the medical device or test procedure.

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Not Related
An AE classified as not related may either be definitely unrelated or simply 
unlikely to be related (ie, there are other more likely causes for the 
AE).
13.7.1.2Intensity (Severity)
Where appropriate, the Investigator must assess the intensity (severity) of the AE as mild, 
moderate, or severe, based on medical judgment with consideration of any subjective 
symptom(s), as defined below:
Mild
An AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom.
Moderate 
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities.
Severe
An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities.
The Investigator must document any action taken (ie, medication, intervention, or treatment 
plan) and outcome of the AE 
 when applicable.
13.8Unmasking of the Study Information
Not applicable; this study is open-label.
13.9Return Product Analysis
Study Sponsor representatives and their contact information are provided in the MOP that 
accompanies this protocol.
Alcon Products associated with 
 product related AEs should be 
returned and must include the Complaint # which will be provided by the Study Sponsor after 
the caseis entered in the Study Sponsor’s Global Product Complaint System (GPCMS).
13.10Follow-Up of Safety Information
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The Investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study.
The Investigator must provide the Study Sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 

Page 49of 74
evaluation of the device. For AEs that are unresolved/ ongoing at time of subject’sexit from 
study, any additional information received at follow-up should be documented in the eCRFs,
up to study completion (ie, database lock).
Any additional data from these follow-up proceduresperformed up to 6 months after subject 
discontinuation or exit must be documented and available upon the Study Sponsor’s request. 
All complaints received after this time period will be considered and processed as 
spontaneous (following the postmarket vigilance procedures) and should be communicated to 
the medical device’s manufacturer as per local requirements.
The Investigator should also report complaints on non-Alcon products directly to the 
manufacturer,as per the manufacturer’s instructions or local regulatory requirements.
13.11Pregnancy in the Clinical Study
Pregnancy is not reportable as an AE; however, complications may be reportable and will be 
decided on a case–by-case basis. An Alcon form will be utilized to capture all pregnancy-
related informationuntil birth of the child.
14DATA REVIEW 
AND HANDLING
14.1Subject Confidentiality
The Investigator must ensure that the subject’s anonymity is maintained throughout the 
course of the study
. In particular, the Investigator must keep an enrollment log with 
confidential identifying information that corresponds to the subject numbers and initials of 
each study participant. At the end of the clinical study, the Study Sponsor will collect a copy 
of the enrollment log without any identifying subject information
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. 
All documents 
submitted to the Study Sponsor will identify the subjects exclusively by number and 
demographic information. No other personally identifying information will be transmitted to 
the Study Sponsor
. The Study Sponsor may release anonymized study data toexternal 
researchers for purposes of future research directly related to the study objectives, or future 
research that is beyond the scope of the current study objectives. The ICF explains this to 
study subjects. 
Anonymization means that all identifiable information will be removed from 
the dataset and all links to the subjects in the study will be removed. Anonymization of the 
data will maintain confidentiality of the subjects who participate in the study so that they 
cannot be identified by external researchers. The anonymized data set will contain records 
from all of the subjects in the current study, but the anonymization process might change the 
data set in some ways, so external researchers will be informed that they might not be able to 
duplicate some of the results from this study. External researchers who request permission to 

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use anonymized data from studies for a new medicine or new indication of a medicine 
(studies for approved medicinal products, small molecule generics, and devices are excluded) 
must be approved by a central independent review panel that will adjudicate the scientific 
request and the competency of the external researcher(s), as well as determine the 
applicability to current standard operating procedures (SOPs). If approved, a data sharing 
agreement will be executed between the Study Sponsor and the external researcher(s), 
committing to a specified analysis and publication timeline. Anonymized data will be 
released to external researchers only after European Union (EU) and/or United States (US) 
submission of the investigational drug/biologic for the study indication. The Study Sponsor 
will not be able to influence the analyses that are performed by external researchers using the 
data from this study once the anonymized data are released.
14.2Completion of Source Documents and Case Report Forms
The nature and location of all source documents will be identified to ensure that original data 
required to complete the electronic case report forms (eCRFs) exists and are accessible for 
verification by the Clinical Site Manager (CSM). It is required that the author of each entryin 
the source documents be identifiable (eg, initials or signature and date).At a minimum, 
source documents should include the following information for each subject:
Subject identification (name, date of birth or age, sex)
Documentation of subject eligibility
Date of informed consent
Dates of visits
Documentation that protocol-specific procedures were performed
Results of studytesting, as required by the protocol
Testarticle accountabilityrecords
Documentation of SAEs and other safety parameters (as applicable)
Records regarding medical histories and the use of concomitant therapies prior to and 
during the study
Date of study completion and reason for early discontinuation, if applicable
Note:
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If electronic source records are maintained, the method of verification must be 
determined in advance of starting the study.

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Direct access to source documentation (medical records) must be allowed for the purpose of 
verifying that the data recorded on the eCRF are consistent with the original source data. 
Data reported on theeCRFs shall be derived fromsource documents and be consistent with 
these source documents, and any discrepancies shall be explained in writing.Anychange or 
correction to data reported on asource document shall be dated, initialed, and explained if 
necessary, and shall not obscure the original entry(ie, an audit trail shall be maintained); this 
applies to both written and electronic changes andcorrections. eCRFs shall be signed and 
dated by the Principal Investigator or his/her authorized designee(s).
14.3Data Review and Clarifications
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Upon completion of the eCRFs, targeted data will be reviewed by the assigned Sponsor 
global CSM team for accuracy and completeness. The planned source document verification 
and overall monitoring activities for this study are outlined in a separate document, the 
Protocol Monitoring Plan. Corrections and/or any necessary additions to the data will be 
applied and if required, queries will be generated. Designated investigative staff are expected 
to respond to data queries in a timely manner and ensure that the corrections and changes 
made to the data are reflected in the subjects’ source documentation.
Deviations from this protocol, regulatory requirements and GCP must be recorded. 
An 
explanation of the deviation should be included, as applicable. In addition, corrective and 
preventive action should be identified, implemented and documented within the study 
records. Prior to study start, a plan for data validation will be completed by Alcon clinical 
data management, and agreed upon by the study clinical manager (CM) and other team 
members.
Concomitant medications entered into the database will be coded using the WHO Drug 
Reference List. Operative medications will be detailed in site-specific surgical study 
protocols and will not be entered in the eCRFs; any exceptions to the site’s standard surgical 
protocol for the study will require entry into the eCRF
. The surgical protocol will be reviewed 
by the Sponsor prior to the site enrolling subjects, kept with the site’s study files,and 
archived in the Sponsor Trial Master File. Medical history and adverse events will be coded 
using the medical dictionary for regulatory activities (MedDRA) terminology. In addition, 
standardized definitions to allow for additional supportive characterization of AEs based on
Postoperative Adverse Event Deﬁnitions for Intraocular Lenses are provided in the 
appendices, Table18-1, and will be collected in eCRFs. Upon completion of the study and 
once the database is declared completed and accurate, the database will be locked and data 
will be available for data analysis. Any changes to the database after lock will be 
implemented upon agreement between the Sponsor’s clinical trial management, medical 

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safety clinical data management,and biostatistics departments, and will be completed 
following the Sponsor’s procedures for changes to a database after database lock.
14.4Quality Assurance and Quality Control
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The Study Sponsor will secure agreement from all involved parties to ensure direct access to 
all study related sites, source data and documents, and reports for the purpose of monitoring 
and auditing by the Study Sponsor, and inspection by domestic and foreign regulatory 
authorities. Quality control will be applied to each stage of data handling to ensure that all 
data are reliable and have been processed correctly. 
Agreements made by the Study Sponsor 
with the Investigator/Institution and any other parties involved in the clinical study will be 
provided in writing as part of the protocol or as a separate agreement.

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15ANALYSIS PLAN
15.1Subject Evaluability
The final subject evaluability will be determined prior to locking the database.
15.2 Analysis Data Sets
The primary analysis set for effectiveness analyses will be the All-Implanted Analysis Set 
(AAS). AAS includes all eyes with successful test article implantation. Additional analyses, 
including the co-primary analysis,will be conducted using the Best-Case Analysis Set (BAS). 
BAS includes all eyes successfully implanted with the test article that had:
at least 1 postoperative visit
no pre-operative ocular pathology
no macular degeneration detected at any time
no previous surgery for the correction of refractive errors
The Rotation Analysis Set (RAS) will include all eyes with successful test article 
implantation from a sub-set of approximately 6 clinical sites that examine subjects for 
rotational stability.
Safety Analysis Set will include all eyes with attemptedimplantation with the test article 
(successful or aborted after contact with the eye) and will be used for the safety analyses.
15.3Demographics and Baseline Characteristics
Summary statistics will be provided for demographic and baseline characteristics. Number 
and percentage will be presented for categorical variables and descriptive statistics including 
mean, standard deviation, minimum,and maximum will be presented for continuous 
variables.
15.4Performance Analyses
15.4.1Primary Performance
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The primary effectiveness endpoint is monocular BCDVA. The number and percentage of 
subjects with BCDVA
 of 0.3 logMAR or better at 12 months postoperative(Visit 5) will be 
summarized along with the corresponding one-sided exact 95% upper confidence limit.

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The performance targets in support of the primary effectiveness objective is to show that the 
one-sided exact 95% upper confidence limit for percentage of subjects with monocular 
BCDVA
 of 0.3logMAR or better at 12 months postoperative (Visit 5) is greater than or equal 
to the SPE rates of 92.5% for the AAS and 96.7% for the BAS. A
 successful outcome on the 
co-primary effectiveness endpoints is indicated by successful outcomes on both of these 
endpoints.
15.4.1.1Statistical Hypotheses
Not applicable.
15.4.1.2Analysis Methods
Categorical statistics (sample size, number in the category, percent in the category
, and the 
corresponding one-sided exact 95% upper confidence limitand two-sided exact 95% 
confidence interval) will be provided for the primary endpoint. In addition, descriptive 
statistics (sample size, mean, median, standard deviation, number of subjects/eyes, minimum, 
maximum, and the two-sided 95% confidence interval)will be provided for BCDVA.In 
addition, the following subgroup analyses will be performed on BCDVAat 12 months 
postoperative (Visit 5):
BCDVA
 by age (<65 years vs. ≥65 years) 
BCDVA
 by investigative site
BCDVA
 by adverse event (study eyes with ocular adverse events vs. study eyes 
without ocular adverse events)
BCDVAby preoperative ocular pathology (study eyes with preoperative ocular 
pathology vs. study eyes withoutpreoperative ocular pathology)
A
 listing of BCDV
A
 at every visit for each study eye will also be provided.
Subject narratives will be provided for the following:
Subject-by-subject analysis of reasons why subject failed to achieve 0.3 logMAR 
BCDVA;

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Frequency of, and the cause of loss of 10 letters or more on an ETDRS chart (or 
equivalent) compared to best post-op BCDVA.

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15.4.2Secondary Performance
The performance target in support of the secondary effectiveness objective is to show that 
IOL rotation at 6 months postoperative (Visit 4) is,
less than 10° in 90 % of eyes in theRAS
less than 20° in 95 % of eyes in theRAS
less than 30° in 99 % of eyes in theRAS
In order to summarize IOL rotation, IOL misplacement and IOL
 misalignment, sample size, 
number, percent and cumulative percent for the following categories will be provided: (<10, 
<20, and <30 degrees, respectively). 
Additional tablesusing the following categories will 
also be provided:(0-5, >5-10, >10-15, >15-20, >20-30, and >30 degrees, respectively).
Difference in IOL
 axis of orientation (in degrees)will be presented for Visit 00 (Operative 
Visit) to Visit 3 (30-45 days postoperative), Visit 00 (Operative Visit) to Visit 4 (120-180 days 
postoperative) and Visit 3 (30-45 days postoperative) to Visit 4 (120-180 days postoperative).
15.4.2.1Statistical Hypotheses
Not applicable. Only descriptive statistics will be presented.
15.4.2.2Analysis Methods
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Categorical statistics will be provided for the secondary endpoint. In addition, descriptive 
statistics (sample size, mean, median, standard deviation, number of subjects/eyes, minimum 
and maximum)will be provided for the secondary endpoint.

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15.4.3.1Statistical Hypotheses and Model
Not applicable.Only descriptive statistics will be presented.
15.4.3.2Analysis Methods
For categorical parameters, the statistics used to summarize the data descriptively include 
sample size, number in the category, and percent in the category
. For continuous parameters, 
the statistics used to summarize the data descriptively include sample size, mean, median, 
standard deviation,number of subjects/eyesminimum, and maximum.
15.5Handling of Missing Data
The AAS and BAS do not include any imputed values. 
Although missing data will occur, the 
influence of the missing data is expected to be minimal.
15.6 Multiplicity
Not applicable.
15.7Safety Analysis
The primary safety objective is to estimate the rate of adverse events (ocular and nonocular, 
serious and non-serious) including SSIs for study eyes at12 months postoperative (Visit 5).
Adverse Events
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Descriptive statistics for adverse events (including SSIs) will be presented for study eyes. 
The rates of all adverse events will be provided with counts and percentages, and these rates 
will be accompanied by two-sided exact 95% confidence intervals.The one-sided exact 95% 
lower confidence limit for incidence rates observed for study eyes will be compared to the 
cumulative and persistent adverse event SPE rates that include SSIs (as reported in EN ISO 
11979-7:2014). An eye with multiple ocular adverse events of the same preferred term is only 
counted once toward the total of this preferred term.The frequency of adverse events, 
separately for cumulative and persistent, will be presentedoverall, stratifiedby age 
(<65years vs. ≥65 years),and by investigative site.
All information obtained on adverse events will be displayed by subject.

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15.8Interim Analyses
Interim reports pertaining to the progress of this study will be submitted to the US FDA for 
review annually until study completion.
15.9Adaptive Study Design
Not applicable.
15.10Sample SizeJustification
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With a sample size of 300 evaluable eyes, the probability to demonstrate that at least 
270(90%) of evaluable eyes implanted with the ClareonIOL
 having monocular best 
corrected distance visual acuity (BCDV
A) of 0.3 logMAR or better at 12 months 
postoperative(Visit 5) is greater than 99%,assuming the mean BCDVA
 is 0.0logMAR 
(SD=0.18for All-Implanted Analysis Set).
Similarly, with a sample size of 300 evaluable eyes, the probability to demonstrate that at 
least 285 (95%) of evaluable eyes implanted with the Clareon IOL having monocular best 
corrected distancevisual acuity (BCDV
A) of 0.3 logMAR or better at 12 months 
postoperative (Visit 5) is greater than 97%,assuming the mean BCDVA
 is 0.0logMAR 
(SD=0.16for Best-Case Analysis Set).
For any event where zero incidence is observed in 300 eyes with Clareon IOL, the one-sided 
exact 95% upper confidence is less than 1%. Thus, with 95% confidence, the true adverse 
event rate is less than 1%.
Approximately 350 subjects will be unilaterally implanted with the Clareon IOL
 in order to 
ensure that at least 300 evaluable subjects complete the study.Sites are expected to enroll 
subjects that have a likelihood of completing the study in order to ensure implanted subjects 

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are followed for the duration of the trial and that a minimum of 300 subjects are seen for each 
reporting period.

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16ADMINISTRATIVE PROCEDURES
16.1Regulatory and Ethical Compliance
This clinical trial will be conducted in accordance with theethicalprinciples contained within 
the following:
The Declaration of Helsinki(DoH), and in compliance with the International Council 
forHarmonisationof Technical Requirements for Pharmaceuticals for Human Use
(ICH) E6 GCP Consolidated Guideline
ISO 14155:2011 Clinical investigation of medical devices for human subjects, Good 
Clinical Practice
Code of Federal Regulations(CFR)
Standard Operating Procedures of Alcon and Contract Research Organizations 
participating in the conduct of the clinical trial, and all other applicable regulations.
The Investigator and all clinical trial staff will conduct the clinical trial in compliance with 
this protocol. The Investigator will ensure that all personnel involved in the conduct of the 
clinical trial are qualified to perform their assigned duties through relevant education, 
training, and experience.
16.2Informed Consent Procedures
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Voluntary informed consent must be obtained from every subject prior to the initiation of any 
screening or other clinical trial-related procedures. The Investigator must have a defined 
process for obtaining consent. Specifically, the Investigator, or designee, will explain the 
clinical trial to each potential subject and the subject must indicate voluntary consent by 
signing and dating the approved informed consent form. The subject must be provided an 
opportunity to ask questions of the Investigator, and if required by local regulation, other 
qualified personnel. The Investigator must provide the subject with a copy of the consent 
form written in a language the subject understands. The consent document must meet all 
applicable local laws and will provide subjects with information regarding the purpose, 
procedures, requirements, and restrictions of the clinical trial, along with any known risks 
and potential benefits associated with the investigational product, the available compensation, 
and the established provisions for maintaining confidentiality of personal, protected health 
information. Subjects will be told about the voluntary nature of participation in the clinical 
trial and will be provided with contact information for the appropriate individuals,should 
questions or concerns arise during the clinical trial. The subject also will be told that their 
records may be accessed by appropriate authorities and Sponsor-designated personnel. The 

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Investigator must keep the original, signed copy of the consent,must provide a duplicate 
copy to each subject, and will record compliance with the informed consent process in 
subjects’ source records.
Amendments may necessitate that the informed consent and other study-related material be 
revised. If the consent formis revised, all subjects currently enrolled in the study must sign 
the approved, revised informed consent, as required by the IRB/IEC.
16.3Responsibilities of the Investigator and IRB/IEC
Before clinical trial initiation, this protocol, the informed consent form, any other written 
information provided to a subject, and any advertisements planned for subject recruitment 
must be approved by an IRB. A
 master list of IRBs for this clinical trial can be found in the 
Trial Master File. The Investigator must provide documentation of IRBapproval to the 
Sponsor. The approval must be dated and must identify the applicable protocol, amendments 
(if any), informed consent form, all applicable recruiting materials(if any), written 
information for subjects(if any), and subject compensation programs. The IRBmust be 
provided with a copy of the Investigator’s Brochure, any periodic safety updates, and all 
other information,as required by local regulation and/or the IRB. 
At the end of the clinical 
trial or in the case of early termination, the Investigator will notify the IRBof the clinical 
trial’s final status. The end of the study is defined as database lock. In case the study is ended 
prematurely, the Investigator will notify the IRB the reasons for the premature termination. 
Finally, the Investigator will report to the IRBon the progress of the clinical trial at intervals 
stipulated by the IRB.
16.4Sponsor and Monitoring Responsibilities
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The Sponsor will designate a monitor to conduct the appropriate site visits at the appropriate 
intervals. The clinical investigation will be monitored, following the Protocol Monitoring 
Plan, to ensure that: the rights and well-being of the subjects are protected; the reported data 
are accurate, complete, and verifiable from the source documents; the equipment used to 
assess variables in the clinical investigation is maintained and calibrated per manufacturer 
instructions and Sponsor requirements; the study is conducted in compliance with the current 
approved protocol (and amendment[s], if applicable), with current GCP, and with applicable 
regulatory requirements.
All investigative sites will have a site initiation. Monitoring will be conducted periodically 
while the clinical study is ongoing. Monitoring methods may include site visits, telephone, 
written and fax correspondence. The assigned CSM will contact each site at appropriate 

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intervals. The Lead CSM (LCSM) will determine the frequency of site visits. Closeout visits 
will take place after the last visit of the last subject.
16.5Regulatory Documentation and Records Retention
Essential documents must be retained by the Investigatorin compliance with the US FDA 
CFR as well as other applicable national regulations. The Investigator(s)/institution(s) must 
comply with record retention stipulations outlined in the Clinical Study
 Agreement. 
Additionally,the Investigator will be supplied with further instruction at study completion.
Additionally, the Investigator must keep study records and source documents until the Study 
Sponsor provides written approval for their destruction. If the Investigator retires, relocates, 
or for any other reason withdraws from responsibility of keeping the study records, then the 
Study Sponsor must be notified and suitable arrangements made for retention of study 
records and source documents needed to comply with national and international regulations 
(generally 2 years after discontinuing clinical development or after the last marketing 
approval).Note: FDA is notified of transfer of records.
16.6Publication of the Clinical Trial
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Any information other than that which is disclosed upon registration should not be discussed 
with persons outside the study. The protocol, study data, and information related to the study 
or to Alcon’s products or research programs that is provided by Alcon (Confidential 
Information) is to be kept confidential, and not disclosed directly or indirectly to any third 
party other than those involved in the study who has a need to know
.
All data and discoveries arising out of the study
, patentable or non-patentable, shall be the 
sole property of Alcon, Inc. Alcon reserves the right of prior review of any publication or 
presentation of information related to the study. 
Alcon may use these data now and in the 
future for presentation or publication at Alcon’s discretion or for submission to government 
regulatory agencies.
The existence of this clinical study is confidential and should not be discussed with persons 
outside of the study. You shall hold confidential, and not disclose directly or indirectly to any 
third party other than those persons involved in the study who have a need to know, the 
protocol, the data arising out of the study, and any other information related to the study or to 
Alcon’s products or a research program that is provided by Alcon to you (the “Confidential 
Information”). All such persons must be instructed not to further disseminate this information 
to others. You shall not use the Confidential Information for any purpose other than the study.

Page 62of 74
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The foregoing obligations of confidence and non-use assumed by you shall not apply to: (a) 
information which at the time of disclosure is in the public domain; (b) information which 
thereafter lawfully becomes part of the public domain other than through disclosure by or 
through you; (c) information which, as evidenced by your written records, was known by you 
prior to Alcon’s disclosure; (d) information which is lawfully disclosed to you by a third party 
not under any obligation of confidence to Alcon; or (e) information which is required to be 
disclosed by law or government regulatory agency
, provided reasonable advance notice of 
such disclosureis given to Alcon.
The Study Sponsor assures that the key design elements of this protocol will be registered in 
www.clinicaltrials.gov as required by current regulations and, if applicable, other public 
databases as required by local country regulations.In addition, results of this study will be 
made publicly available in www.clinicaltrials.gov regardless of outcome as required by 
current regulations and, if applicable, in other public databases as required by local country 
regulations.

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17REFERENCES
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EN ISO 11979-7:2014 Ophthalmic implants –Intraocular lenses –Part 7: Clinical 
Investigations
Isotani H, Fukumoto Y
, Kitaoka H, Furukawa K, Ohsawa N, Utsumi T. Oval pupil in patients 
with diabetes mellitus: examination by measurement of the dark-adapted pupillary area and 
pupillary light reflex. Diabetes Res Clin Pract. 1995;29:43-8.
 
 

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18APPENDICES
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.

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