Post-Approval Study of the TECNIS SYMFONY® Toric Lenses
Phase: NA
Conditions: Cataract, Corneal Astigmatism
Sponsor: Johnson & Johnson Surgical Vision, Inc.

 
 
Study Protocol 
 
POST-APPROVAL STUDY OF THE TECNIS SYMFONY® TORIC 
LENSES 
 
NCT Number: NCT03791619 
Document date: 15 Nov 2018 
 
 
 
 
 
 

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CONFIDENTIAL 
The following contains confidential, proprietary information  
that is the property of Johnson & Johnson Vision 
 
POST-APPROVAL STUDY OF THE TECNIS SYMFONY® TORIC LENSES  
 
PROTOCOL NUMBER:  TIOL-205-STPA 
 
 
SPONSOR: 
Johnson & Johnson Surgical Vision, Inc. 
1700 E. Saint Andrew Place 
Santa Ana, CA 92705 USA 
(714) 247-8200 
 
Investigator Agreement: 
As an Investigator, I agree to: 
 
Implement and conduct this study diligently and in strict compliance with this 
agreement, the protocol, Good Clinical Practices, ISO 14155:2011 and all 
applicable FDA regulations, conditions of approval imposed by the reviewing 
Institutional Review Board (IRB), FDA or other regulatory authorities and all other 
applicable laws and regulations. 
 
Supervise all testing of the device where human subjects are involved. 
 
Ensure that the requirements for obtaining informed consent are met. 
 
Obtain authorization for use/disclosure of health information (e.g., HIPAA 
authorization or equivalent). 
 
Maintain all information supplied by Johnson & Johnson Surgical Vision, Inc. in 
confidence and, when this information is submitted to an independent IRB or any 
other group, it will be submitted with a designation that the material is confidential. 
I have read this protocol in its entirety and I agree to all aspects. 
 
________________________ 
_______________________ 
_______________ 
Investigator Printed Name 
Signature 
Date 
________________________ 
_______________________ 
_______________ 
Sub-Investigator Printed Name 
Signature 
Date 
________________________ 
_______________________ 
_______________ 
Sub-Investigator Printed Name 
Signature 
Date 

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TABLE OF CONTENTS 
TITLE 
PAGE 
 
Table of Contents ............................................................................................................ ii 
Personnel and Facilities ................................................................................................. iv 
Protocol Change History .................................................................................................. v 
1. 
Synopsis ............................................................................................................. 1 
2. 
Background/Introduction ..................................................................................... 6 
3. 
Clinical Hypothesis .............................................................................................. 7 
4. 
Study Design ...................................................................................................... 7 
5. 
Acroynyms .......................................................................................................... 7 
6. 
Study Objectives and Endpoints ......................................................................... 8 
6.1 
Primary Endpoint: ........................................................................................... 8 
6.2 
Other Endpoints: ............................................................................................. 8 
7. 
Study Products ................................................................................................... 9 
7.1 
Intraocular Lenses........................................................................................... 9 
7.2 
IOL Implantation Systems ..............................................................................11 
8. 
Study Population ................................................................................................11 
8.1 
Inclusion Criteria: ...........................................................................................12 
8.2 
Exclusion Criteria: ..........................................................................................13 
9. 
Investigator Approval .........................................................................................14 
9.1 
Investigator Qualifications ..............................................................................14 
9.2 
Investigator Obligations ..................................................................................14 
9.3 
Investigator Approval .....................................................................................15 
10. 
Study Timeline ...................................................................................................16 
11. 
Experimental Plan ..............................................................................................17 
11.1 
Overview ........................................................................................................17 
11.2 
Visit Schedule ................................................................................................18 
11.3 
Preoperative Procedures................................................................................18 
11.4 
Study Lens Supply .........................................................................................20 
11.5 
Operative Procedures ....................................................................................21 
11.6 
Postoperative Procedures ..............................................................................21 
11.7 
Unscheduled Visits.........................................................................................23 
11.8 
Exit of Subjects ..............................................................................................25 
11.9 
Protocol Deviations ........................................................................................26 
12. 
Adverse Events and Product Complaints ...........................................................26 
12.1  
Adverse Event and Complaint Definitions ......................................................26 
12.2 
Product Complaint/Device Deficiency Definition .............................................28 
12.3  
Adverse Event and Complaint Reporting Requirements .................................29 
12.4  
Causal Relationship .......................................................................................30 
12.5  
Adverse Event Follow-Up ...............................................................................30 
13. 
Protocol Changes and Procedures ....................................................................31 
14. 
Ethics Review and Patient Welfare ....................................................................31 
14.1 
Institutional Review Board (IRB) .....................................................................31 
14.2 
Informed Consent ..........................................................................................31 
15. 
Documentation ...................................................................................................32 
15.1 
Source Documents.........................................................................................32 
15.2 
Subject Confidentiality ....................................................................................32 
15.3 
Case Report Form Completion .......................................................................33 
15.4 
Study Summary .............................................................................................33 
16. 
Monitoring ..........................................................................................................33 

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16.1 
Data Monitoring ..............................................................................................33 
16.2 
Administrative Monitoring ...............................................................................33 
16.3 
Medical Oversight ..........................................................................................34 
17. 
Publications .......................................................................................................35 
18. 
Risk Analysis .....................................................................................................35 
19. 
Record Retention ...............................................................................................36 
20. 
Termination of the Investigation .........................................................................37 
21. 
Statistical Methods .............................................................................................37 
21.1 
Analysis Population ........................................................................................37 
21.2 
Primary Endpoint ...........................................................................................38 
21.3 
Additional Endpoints ......................................................................................39 
21.4 
Interim Reports ..............................................................................................39 
21.5 
Sample Size Calculations...............................................................................40 
22. 
References ........................................................................................................40 
Appendix A - Summary of Examinations for Each Visit ..................................................41 
 
 
Appendix D - Slit-Lamp Exam Ratings ...........................................................................53 
 

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PERSONNEL AND FACILITIES 
 
SPONSOR: 
Abbott Medical Optics Inc./ 
 
Johnson & Johnson Surgical Vision, Inc. (“JJSV”) 
 
1700 E. Saint Andrew Place 
 
Santa Ana, CA 92705 
 
Main Number:  714-247-8200 
 
Fax:  714-247-8784 
 
SPONSOR PERSONNEL: 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EMERGENCY TELEPHONE NUMBER: 
 

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PROTOCOL CHANGE HISTORY 
Version 
Section(s) 
Description of Change(s)  
Rationale for Change(s) 
1.0 
N/A 
Original 
N/A 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 

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1. 
SYNOPSIS 
PROTOCOL TITLE: 
Post-Approval Study of the TECNIS Symfony® Toric 
Lenses 
Protocol Number:  
TIOL-205-STPA 
STUDY TREATMENTS: 
Toric Study Lenses:  
 TECNIS Symfony Toric Extended Range of Vision 
IOL (Symfony Toric), Model ZXT300  
 TECNIS Symfony Toric Extended Range of Vision 
IOL (Symfony Toric), Model ZXT375  
Toric Control Lens:  
 TECNIS Symfony Toric Extended Range of Vision 
IOL (Symfony Toric), Model ZXT150  
Other Study Lenses (may be used for fellow eyes): 
 TECNIS Symfony Toric Extended Range of Vision 
IOL (Symfony Toric), Model ZXT225 
 TECNIS Symfony Extended Range of Vision IOL 
(Symfony), Model ZXR00   
STUDY OBJECTIVE: 
The purpose of this post-approval study is to 
evaluate the rates of bothersome visual symptoms in 
a larger population in clinical practice for the TECNIS 
Symfony Toric IOLs with approximately 2.0 D or 
more of cylinder correction at the corneal plane 
(Models ZXT300 and ZXT375, higher-cylinder 
group), compared to the Symfony Toric IOL with 
approximately 1.0 D of cylinder correction at the 
corneal plane (Model ZXT150, lower-cylinder group), 
and to ensure the continued safety of the approved 
devices.  
CLINICAL HYPOTHESIS: 
The rate of bothersome visual symptom items 
 
 
for the Symfony Toric IOL higher-cylinder 
group will be comparable to that of the lower-cylinder 
group.   
 
  

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OVERALL STUDY DESIGN: 
Structure: 
Prospective, multicenter, bilateral, non-randomized, 
open-label, comparative clinical study 
Number of Sites: 
Up to 50 sites in the USA 
Duration: 
6 months; however, any subject that undergoes a 
lens repositioning procedure due to IOL 
misalignment, or 
 
 
 
at 6 months, will be followed through 
1 year postoperatively.  
Administration: 
Surgeons will perform routine small-incision, cataract 
surgery and use the JJSV-recommended 
implantation systems for lens implantation.  
Refractive target outcomes will be emmetropia for 
both eyes.  
Visit Schedule: 
Subjects will be bilaterally implanted; the second eye 
is to be implanted within approximately one month 
after the first-eye surgery.   
All subjects will undergo a minimum of 9 visits: 
Preoperative for both eyes; Operative, 1-day and 
1-week visits for each eye; and 1-month and 6-month 
visits for both eyes together.  In addition, a 1-year 
postoperative visit will be required for subjects who 
undergo a lens repositioning procedure due to IOL 
misalignment at any time during the study, and for 
subjects who report 
 
 
visual symptoms 
 
 at 6 months. 
STUDY POPULATION CHARACTERISTICS: 
Condition: 
Bilateral cataracts with corneal astigmatism in at 
least 1 eye of approximately 2.00 D to 3.00 D 
(higher-cylinder group) or approximately 1.00 D to 
1.50 D (lower-cylinder group) based on the 
combination of preoperative keratometric cylinder, 

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the expected effect of surgically-induced astigmatism 
(SIA), use of the optional posterior corneal 
astigmatism (PCA) algorithm and TECNIS Symfony 
Toric Calculator outcomes of ZXT300 or ZXT375 
(higher-cylinder group ) or ZXT150 (lower-cylinder 
group). 
Number of subjects: 
Up to 634 subjects will be enrolled to achieve 
bilateral implantation in approximately 506 subjects, 
resulting in approximately 240 evaluable subjects in 
the higher-cylinder group and 240 evaluable subjects 
in the lower-cylinder group at 6 months 
 
   
This is a bilateral study; both eyes must be implanted 
with a TECNIS Symfony IOL, either toric (Models 
ZXT150, ZXT225, ZXT300 or ZXT375) or non-toric 
(TECNIS Symfony Extended Range of Vision IOL, 
Model ZXR00).  Each eye may have a different 
TECNIS Symfony IOL implanted, as determined by 
the surgeon and the TECNIS Symfony Toric IOL 
calculator; however, at least one eye must be 
implanted with either a Symfony Toric IOL Model 
ZXT150 (lower-cylinder group) or a Model ZXT300 or 
ZXT375 (higher-cylinder group) and the fellow eye 
must have the same or a lower toric power.  The eye 
with the highest toric power IOL will determine the 
model group. 
NOTE:  No site may enroll more than 25% of the 
enrollment total. 
Inclusion Criteria (all study criteria apply to each study eye unless otherwise 
indicated):  
 
Minimum 22 years of age 
 
Bilateral cataracts for which phacoemulsification extraction and posterior 
chamber IOL implantation have been planned 
 
Preoperative keratometric cylinder of: 
o 
Approximately 2.00 D to 3.00 D resulting in a calculated lens power (using 
the web-based TECNIS Symfony Toric IOL Calculator) that requires 
implantation of a ZXT300 or ZXT375 IOL in at least one eye for the subject to 
be eligible for the higher-cylinder group, or 

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o 
Approximately 1.00 D to 1.50 D resulting in a calculated lens power (using 
the web-based TECNIS Symfony Toric IOL Calculator) that requires 
implantation of a ZXT150 IOL in at least one eye for the subject to be eligible 
for the lower-cylinder group  
o 
The eye with the higher toric power IOL will determine the model group 
o 
The fellow eye must be the same or a lower toric power 
 
Predicted residual refractive cylinder based on the TECNIS Symfony Toric IOL 
calculator, taking surgically-induced astigmatism into account and using the 
posterior corneal astigmatism option, must be ≤0.50 D for all toric eyes  
 
Clear intraocular media other than cataract in each eye 
 
Availability, willingness, ability and sufficient cognitive awareness to comply with 
examination procedures and study visits 
 
Ability to understand, read and write English in order to consent to study 
participation and complete study questionnaires 
 
Signed informed consent and HIPAA authorization  
Exclusion Criteria (all study criteria apply to each study eye):  
 
Irregular corneal astigmatism  
 
Any clinically-significant corneal pathology/abnormality other than regular 
corneal astigmatism  
 
Previous corneal surgery 
 
Recent ocular trauma or intraocular surgery that is not resolved/stable or may 
affect visual outcomes 
 
Any clinically-significant pupil abnormalities (non-reactive, fixed pupils, or 
abnormally-shaped pupils)  
 
Subjects with conditions associated with increased risk of zonular rupture, 
including capsular or zonular abnormalities that may lead to IOL decentration, 
including pseudoexfoliation, trauma, or posterior capsule defects 
 
Known ocular disease or pathology that, in the opinion of the investigator, 
may affect visual acuity or require surgical intervention during the course of 
the study (macular degeneration, cystoid macular edema, diabetic 
retinopathy, uncontrolled glaucoma, etc.) 
 
Concurrent participation or participation during 30 days prior to preoperative 
visit in any other clinical study 
 
Planned monovision correction 
 
Patient is pregnant, plans to become pregnant, is lactating or has another 
condition associated with the fluctuation of hormones that could lead to 
refractive changes 

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EVALUATION CRITERIA: 
The purpose of this post-approval study is to evaluate the rates of bothersome visual 
symptoms for the higher-cylinder Symfony Toric IOLs, Models ZXT300 and ZXT375, 
compared to the lower-cylinder Symfony Toric IOL, Model ZXT150.  The first primary 
endpoint is the rate of bothersome visual symptoms 
 
 
 
.  The second primary endpoint will be the rate of 
those having a lot of difficulty with an activity due halos, glare or starbursts as measured 
in the PRVSQ. 
Other endpoints are individual visual symptom ratings included in the PRVSQ, rates of 
IOL repositioning procedures (secondary surgical intervention) due to IOL misalignment,  
rates of explants due to visual symptoms, distance visual acuities, mean percent 
reduction in absolute cylinder, mean refractive cylinder, mean refractive cylinder 
compared to the preoperatively-predicted cylinder, mean spherical equivalent, spherical 
equivalent compared to the preoperatively-predicted spherical equivalent, percent of 
eyes with cylinder and spherical equivalent (MRSE) within 0.50 D and within 1.00 D of 
the preoperatively-predicted spherical equivalent, rates of medical and/or lens findings, 
and rates of other adverse events.  Preoperatively-predicted values will be based upon 
those generated from the TECNIS Symfony Toric IOL calculator.   
DATA ANALYSIS: 
The key time frame for analysis will be the 6-month visit.  The first primary endpoint for 
this study will be the rate of bothersome visual symptoms,
 
 
.  
The second primary endpoint will be the rate of those having a lot of difficulty with an 
activity due to halos, glare or starbursts as measured in the PRVSQ.   The primary 
endpoint results will be compared between higher-cylinder toric IOL subjects and lower-
cylinder toric control IOL subjects at the 6-month visit.  The frequency, proportion and 
95% Confidence Interval (CI) will be reported for higher-cylinder and lower-cylinder 
control subjects.  This will be done for the higher-cylinder (ZXT300 and ZXT375) and 
lower-cylinder (ZXT150) groups. 
Descriptive statistics will be used for reporting results.  Visual acuity data will be reported 
by acuity line achieved.  For questionnaire items, the frequency and proportion for each 
response will be reported.  For refractive data, descriptive statistics will include mean, 
standard deviation, median, minimum and maximum and also the percent achieving 
absolute values within 0.50 D and 1.00 D of preoperatively-predicted values.  

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The frequency and proportion of primary and fellow eyes with adverse events or 
medical/lens findings will also be reported.   
STUDY VISITS AND PROCEDURES: 
Inclusion and exclusion qualifications will be assessed at the preoperative visit according 
to the inclusion/exclusion criteria.  The Informed Consent Document and Authorization 
for Use/Disclosure of Health Information form (HIPAA authorization) must be signed by 
any patients who agree to participate in the study prior to undergoing any study-specific 
procedures.  Each subject will receive Symfony IOLs in both eyes, according to the 
TECNIS Symfony Toric IOL calculator, and will be placed in either the higher-cylinder 
group or the lower-cylinder control group based on the IOL with the highest toric power.  
Key preoperative data include ocular health and history, distance visual acuities, 
manifest refraction, keratometry, biomicroscopic slit-lamp findings, ocular symptoms and 
biometry.  The operative visit will include standard procedures for cataract surgery and 
IOL implantation.  Key postoperative data collection includes non-directed visual 
symptoms, questionnaires, distance visual acuities, manifest refraction, keratometry, 
slit-lamp findings and adverse events.   
2. 
BACKGROUND/INTRODUCTION 
Amongst patients undergoing cataract surgery, approximately 35-41% of cataract 
patients have ≥ 0.75 diopter of corneal astigmatism, with 15%-20% having ≥ 1.5 D of 
corneal astigmatism.1,2  Although there are various modalities to reduce the amount of 
astigmatism during cataract surgery (e.g., limbal relaxing incisions, etc.), toric IOLs are 
now commonly used for correction of aphakia and pre-existing ocular astigmatism.   
The TECNIS Symfony Extended Range of Vision IOLs were designed in response to a 
patient need for lenses that can provide good distance vision, improved intermediate and 
near vision compared to standard monofocal IOLs, and less dysphotopsia compared to a 
multifocal IOL.  The Symfony IOLs utilize diffractive technology to mitigate the effects of 
presbyopia by providing an extended depth of focus, while keeping visual symptoms to a 
minimum and reducing chromatic aberration.  In addition, the Symfony Toric IOLs 
include an anterior aspheric optic with a toric surface to correct for ocular astigmatism.   
On July 15, 2016, JJSV received USA FDA approval (P980040/S065) for the TECNIS 
Symfony Extended Range of Vision IOL, Model ZXR00, and the TECNIS Symfony Toric 
Extended Range of Vision IOLs, Models ZXT150, ZXT225, ZXT300 and ZXT375, for the 
visual correction of aphakia and pre-existing corneal astigmatism of 1 diopter or greater.  
Compared to an aspheric monofocal IOL, the lens provides improved intermediate and 
near visual acuity, while maintaining comparable distance visual acuity.  
 
 
 

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3. 
CLINICAL HYPOTHESIS 
The rate of bothersome visual symptom items 
 
 for the 
Symfony Toric IOL higher-cylinder group will be compared to the rate for the 
lower-cylinder group.  The bothersome visual symptom items of interest are halos, glare, 
and starbursts. 
4. 
STUDY DESIGN 
This study is a prospective, multicenter, bilateral, non-randomized, open-label, 
comparative, 6-month clinical study conducted at up to 50 sites in the USA.  Subjects 
who meet the inclusion/exclusion criteria will be bilaterally implanted with Symfony IOLs, 
with either 1) Model ZXT300 or ZXT375 IOLs (higher-cylinder group), or 2) control Model 
ZXT150 (lower-cylinder control group) IOL, implanted in at least one eye, according to 
the TECNIS Symfony Toric IOL calculator.  The fellow eye will be allowed to have any 
Symfony IOL implanted, according to the TECNIS Symfony Toric IOL calculator, 
provided it is the same or a lower toric power as the primary eye.  The eye with the 
highest toric power IOL will determine the model group.  
JUSTIFICATION OF STUDY DESIGN 
 
 
 
 
 
5. 
ACROYNYMS 
The following acronyms are used throughout the document: 

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 
UCDVA:  uncorrected distance visual acuity 
 
BCDVA:  best corrected distance visual acuity 
 
D:  diopters 
6. 
STUDY OBJECTIVES AND ENDPOINTS 
The objective of this post-approval study is to evaluate the rate of bothersome visual 
symptoms 
 
 at 6 months for the Symfony Toric IOLs with 
approximately 2.0 D or more of cylinder correction at the corneal plane (Models ZXT300 
and ZXT375) in a larger population in clinical practice compared to the control IOL 
(Symfony Toric Model ZXT150 IOL), and to ensure the continued safety of the approved 
devices.   
Study endpoints will be evaluated at 6 months postoperatively.   
6.1 
PRIMARY ENDPOINT: 
The primary co-endpoints are the rate of bothersome visual symptoms and the rate of 
difficulty with an activity due to the symptoms at 6 months postoperative.  
 
 
  The rate of difficulty with an 
activity due to the symptoms is determined by the percentage of subjects who respond 
“Yes” to the question “Is there anything you have a lot of difficulty with, or do not do, 
because of (visual symptom) at 6 months postoperative.  
 
  
 
 
 
 
 
 
The frequency and proportion of subjects reporting one or more of these items
 
 via PRVSQ questionnaire will be used to 
determine the primary endpoint. This rate will be calculated for the higher-cylinder 
(ZXT300 and ZXT375) and lower-cylinder (ZXT150) groups. 
6.2 
OTHER ENDPOINTS: 
 
Other questionnaire responses, such as rates of degree of bother 
 
Rates of IOL repositioning procedures (secondary surgical intervention) due to 
IOL misalignment 
 
Rate of explants related to visual symptoms  
 
Rates of other adverse events  
 
Monocular uncorrected distance visual acuity 
 
Monocular best corrected distance visual acuity 

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 
Mean percent reduction in absolute cylinder 
 
Mean refractive cylinder and mean refractive cylinder compared to 
preoperatively-predicted cylinder 
 
Mean spherical equivalent and mean spherical equivalent compared to 
preoperatively-predicted spherical equivalent 
 
Percent of eyes with absolute cylinder within 0.50 D and within 1.00 D of 
preoperatively-predicted cylinder 
 
Percent of eyes with spherical equivalent within 0.50 D and within 1.00 D of 
preoperatively-predicted spherical equivalent 
 
Rates of medical and/or lens findings 
7. 
STUDY PRODUCTS 
7.1 
INTRAOCULAR LENSES 
TECNIS Symfony IOLs, both toric and non-toric, are posterior-chamber, 1-piece, 
aspheric, hydrophobic acrylic foldable IOLs and are to be implanted in the capsular bag 
following cataract extraction.  The Symfony IOLs have a spherical posterior optic with a 
diffractive surface to provide an extended depth of focus and an anterior aspheric optic; 
the Symfony Toric IOLs also have a toric surface to correct for ocular astigmatism.   
The TECNIS Symfony Toric Model Series ZXT IOLs included in this study are intended 
for cataract patients with pre-existing corneal astigmatism that, when taking 
surgically-induced astigmatism into account and using the TECNIS Symfony Toric 
Calculator’s PCA algorithm, have approximately 2.00 D to 3.00 D (higher-cylinder group) 
or 0.75 D – 1.50 D (lower-cylinder group) of predicted corneal astigmatism to be 
corrected (Table 1).   
TABLE 1 
Symfony Toric IOL Astigmatism Correction Range 
ZXT IOL 
Model 
Cylinder Power (D) 
Correction Range Based on 
Combined Corneal Astigmatism  
(Preoperative Kcyla + SIAb) 
IOL Plane 
Corneal Plane 
ZXT150 
1.50 
1.03 
0.75 – 1.50 D 
ZXT225 
2.25 
1.55 
1.50 – 2.00 D 
ZXT300 
3.00 
2.06 
2.00 – 2.50 D 
ZXT375 
3.75 
2.57 
2.50 – 3.00 D 
a Keratometric cylinder 
b Surgically-induced astigmatism 
c Model ZXT225 eyes may be included in the study; however, the fellow eye must require either a ZXT300 or 
ZXT375 IOL.  Model ZXT225 is not the subject of this study. 
The Model ZXT IOLs have two sets of four axis orientation marks 180o apart in the outer 
periphery of the anterior optic surface (Figure 1) to indicate the meridian of the lowest 
power (flat meridian).  These axis orientation marks are for proper alignment of the flat 
meridian of the IOL with the steep meridian of the corneal curvature. 

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FIGURE 1: Drawing and Photograph of a Model Series ZXT IOL 
           
 
INDICATION  
The TECNIS Symfony Toric Extended Range of Vision IOLs, including Models ZXT150, 
ZXT225, ZXT300, and ZXT375, are indicated for primary implantation for the visual 
correction of aphakia and for reduction of residual refractive astigmatism in adult patients 
with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a 
cataractous lens has been removed.  The lens mitigates the effects of presbyopia by 
providing an extended depth of focus.  Compared to an aspheric monofocal IOL, the 
lens provides improved intermediate and near visual acuity, while maintaining 
comparable distance visual acuity.  The Model Series ZXT IOLs are intended for 
capsular bag placement only.  Note that Model ZXT225 may be included in the study; 
however, the fellow eye must require either a Model ZXT300 or ZXT375 IOL.  Model 
ZXT225 is not the subject of this study. 
The TECNIS Symfony Extended Range of Vision IOL, Model ZXR00, is indicated for 
primary implantation for the visual correction of aphakia in adult patients with less than 
1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been 
removed.  The lens mitigates the effects of presbyopia by providing an extended depth 
of focus.  Compared to an aspheric monofocal IOL, the lens provides improved 
intermediate and near visual acuity while maintaining comparable distance visual acuity.  
The Model ZXR00 IOL is intended for capsular bag placement only.  Note that Model 
ZXR00 will only be implanted in fellow eyes for this study. 
STORAGE AND DISTRIBUTION 
All lenses will be obtained from the site’s own inventory.  All study lenses should be 
stored in the original packaging and kept in a dry place.  Lenses should not be stored in 
direct sunlight or at temperatures greater than 45° C (113°F).  Each lens is packaged in 
a lens tray and sealed in a peel-pouch.  The lens is sterile as long as the package has 
not been opened or damaged and the shelf-life expiration date has not been exceeded. 

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Table 2 lists the general design characteristics of the Symfony Toric IOLs: 
TABLE 2 
Lens Characteristics of the Symfony Toric Model ZXT 
CHARACTERISTICS 
Symfony Toric IOL Model Series ZXT 
 
Lens Design 
1-piece foldable posterior-chamber lenses with a toric-aspheric anterior 
surface, a diffractive design on the posterior surface, and a maximum 
and a minimum radii of curvature perpendicular to each other 
Lens Model 
Surface-treated SENSAR®  soft acrylic (hydrophobic acrylic with a 
covalently-bound UV absorber) 
DIMENSIONAL FEATURES 
Overall Diameter 
13.0 mm 
Optical Center Thickness 
0.7 mm (20.0 D Lens) 
Haptic Angle 
No angulation, but offset from the optic body 
Optic Body Diameter 
6.0 mm 
Haptic Material 
Same as optic 
Haptic Width 
0.39 mm 
Haptic Thickness 
0.46 mm 
Haptic Style 
TRI-FIX Design Modified C, integral with optic 
Other Features 
Axis orientation marks  
OPTICAL FEATURES 
Optic Shape 
Biconvex 
Anterior Optic Profile 
Toric aspheric with a maximum and a minimum radii of curvature 
perpendicular to each other 
Posterior Optic Profile 
Spherical 
Optic Edge Design 
PROTEC™ squared posterior edge 
Dioptric Power Range 
+5.0 to +34.0 D in 0.50 D increments 
Cylinder Power Range 
1.50 D, 2.25 Db, 3.00 D and 3.75 D (at the IOL plane) 
Refractive Index 
1.47 (at 35° C) 
Theoretical A-constanta 
118.8 for ultrasound biometry 
119.3 for optical biometry 
a For lens power calculations, the investigator’s personalized A-Constant or Surgeon Factor for the TECNIS 
Symfony Model ZXR00 IOL or TECNIS Symfony Toric Model ZXT IOLs is to be used. 
 
 
 
7.2 
IOL IMPLANTATION SYSTEMS 
 
 
 
 
   
8. 
STUDY POPULATION 
All study subjects will be enrolled from the normal surgical cataract population at up to 
50 sites in the U.S.A.  This study will include only subjects intended to undergo bilateral 
primary phacoemulsification cataract extraction and IOL implantation who have either 
approximately 2.00 D to 3.00 D (higher-cylinder group) or approximately 1.00 D to 

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1.50 D (lower-cylinder control group) of corneal astigmatism requiring correction in at 
least one eye.  The lenses to be implanted will be calculated using the TECNIS Symfony 
Toric Calculator and based on the combination of preoperative keratometric cylinder, the 
expected effect of SIA and the PCA algorithm.  
 
 
 
 
  The eye with the 
highest toric power IOL will determine the model group.  
Up to 634 subjects will be enrolled to achieve approximately 506 bilaterally implanted 
subjects, resulting in approximately 480 evaluable subjects at 6 months, 240 in the 
higher-cylinder group and 240 in the lower-cylinder group.  
 
  
 
 
 
 
  The eye implanted with the highest 
toric power IOL will determine the model group.  
All patients who sign the informed consent will be enrolled in the study and subjects that 
meet the inclusion and exclusion criteria (Section 8.1 and 8.2) in both eyes will be 
offered treatment in the study.  Eligibility criteria may not be waived by the investigator.  
Any questions regarding patient eligibility are to be discussed with JJSV prior to subject 
treatment.  Those subjects who meet the criteria and agree to participate will be enrolled 
in either the higher-cylinder group or the lower-cylinder group, according to the TECNIS 
Symfony Toric IOL calculator.  Subjects will be treated sequentially at each site until the 
total recruitment goals for each lens model are met.   
8.1 
INCLUSION CRITERIA: 
Note: All criteria apply to each eye unless otherwise indicated: 
 
Minimum 22 years of age 
 
Bilateral cataracts for which phacoemulsification extraction and posterior 
chamber IOL implantation have been planned 
 
Preoperative keratometric cylinder of: 
o 
Approximately 2.00 D to 3.00 D resulting in a calculated lens power (using 
the web-based TECNIS Symfony Toric IOL Calculator) that requires 
implantation of a ZXT300 or ZXT375 IOL in at least one eye for the subject to 
be eligible for the higher-cylinder group, or 

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o 
Approximately 1.00 D to 1.50 D resulting in a calculated lens power (using 
the web-based TECNIS Symfony Toric IOL Calculator) that requires 
implantation of a ZXT150 IOL in at least one eye for the subject to be eligible 
for the lower-cylinder group  
o 
The eye with the higher toric power IOL will determine the model group 
o 
The fellow eye must be the same or a lower toric power 
 
Predicted residual refractive cylinder based on the TECNIS Symfony Toric IOL 
calculator, taking surgically-induced astigmatism into account and using the 
posterior corneal astigmatism option, must be ≤0.50 D for all toric eyes 
 
Clear intraocular media other than cataract in each eye 
 
Availability, willingness, ability and sufficient cognitive awareness to comply with 
examination procedures and study visits 
 
Ability to understand, read and write English in order to consent to study 
participation and complete study questionnaires 
 
Signed informed consent and HIPAA authorization 
8.2 
EXCLUSION CRITERIA: 
Note: All criteria apply to each eye  
 
Irregular corneal astigmatism  
 
Any clinically-significant corneal pathology/abnormality other than regular corneal 
astigmatism  
 
Previous corneal surgery 
 
Recent ocular trauma or intraocular surgery that is not resolved/stable or may 
affect visual outcomes 
 
Any clinically-significant pupil abnormalities (non-reactive, fixed pupils, or 
abnormally-shaped pupils)  
 
Subjects with conditions associated with increased risk of zonular rupture, 
including capsular or zonular abnormalities that may lead to IOL decentration, 
including pseudoexfoliation, trauma, or posterior capsule defects 
 
Known ocular disease or pathology that, in the opinion of the investigator, may 
affect visual acuity or require surgical intervention during the course of the study 
(macular degeneration, cystoid macular edema, diabetic retinopathy, 
uncontrolled glaucoma, etc.) 
 
Concurrent participation or participation during 30 days prior to preoperative visit 
in any other clinical study 
 
Planned monovision correction 
 
Patient is pregnant, plans to become pregnant, is lactating or has another 
condition associated with the fluctuation of hormones that could lead to refractive 
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9. 
INVESTIGATOR APPROVAL  
9.1 
INVESTIGATOR QUALIFICATIONS 
JJSV will select ophthalmic surgeons who have completed a residency in ophthalmology 
(or its documented equivalent) and are licensed to practice medicine and perform 
surgery at his/her investigative site.  
 
   
 
 
 
.  All sites are required to have 
adequate staff support for reporting and subject follow-up, as well as the necessary 
instrumentation to conduct study testing. 
9.2 
INVESTIGATOR OBLIGATIONS 
Investigators are required to fulfill the following obligations: 
 
Conduct the study in accordance with the relevant and current protocol.  
Investigator will only make changes to a protocol after notifying and obtaining 
approval from JJSV, the FDA, and the Institutional Review Board (IRB), except 
when necessary to protect the safety, rights or welfare of subjects 
 
Personally conduct and supervise the study 
 
Maintain a list of appropriately qualified persons to whom the investigator has 
delegated significant study-related duties 
 
Be responsible for protecting the rights, safety and welfare of subjects under the 
investigator’s care 
 
Maintain confidentiality as required by HIPAA or similar laws and regulations 
 
Shall not obtain written informed consent of any subject to participate or allow 
any subject to participate before FDA and IRB approval are obtained 
 
Document in each subject’s case history that informed consent was obtained 
prior to participation in the study  
 
Report to JJSV any adverse experiences and/or device defects or malfunctions 
that occur during the course of the study in accordance with applicable laws and 
regulations 
 
Maintain adequate and accurate records in accordance with applicable laws and 
regulations and make available all study documents and subject medical records 
for inspection by either JJSV, duly authorized regulatory agencies (e.g., FDA, 
PMDA, Health Canada, etc.) and/or the IRB 
 
Submit progress reports on the study to JJSV and the reviewing IRB at regular 
intervals, but no less often than yearly as required by the FDA Guidance 
Document on PAS "Procedures for Handling Post-Approval Studies Imposed by 
PMA Order," dated June 15, 2009. 

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 
Ensure the IRB that is responsible for initial and continuing review of the study 
complies with applicable laws and regulations 
 
Report all changes in research activity and all unanticipated problems involving 
risks to subjects to the IRB and JJSV 
 
Submit a final report to JJSV and reviewing IRB within 3 months after termination 
or completion of the study or the investigator’s part in the study 
 
Provide sufficient accurate financial information to JJSV to allow JJSV to submit 
complete and accurate certification or disclosure statements as required by 
21CFR54.  Promptly update this information if any relevant changes occur during 
the course of the study or for up to one year following completion of the study 
 
Comply with all other obligations of clinical investigators and requirements 
according to all applicable FDA regulations, all other applicable laws and 
regulations and all conditions of approval imposed by the reviewing IRB and FDA  
 
Ensure that all associates, colleagues and employees assisting in the conduct of 
the study are adequately informed about the protocol, the study devices, their 
study-related duties and functions and agree to fulfill their obligations in meeting 
the above commitments. 
Investigators shall provide adequate time and resources to conduct and report on the 
study.  The Investigator, or delegate, shall notify JJSV of any change in the conduct of 
the study including changes in study personnel assigned to the study project, location of 
the study device(s), or maintenance of study records, etc. 
9.3 
INVESTIGATOR APPROVAL 
It is the responsibility of the investigator to obtain prospective approval of the study 
protocol, protocol amendments or changes, informed consent forms and other relevant 
documents (e.g., advertisements) from the IRB.  
 
 
 sites will obtain IRB approvals and fulfill 
any other site-specific regulatory requirements.   
The investigator is required to report to JJSV within five working days any withdrawal of 
approval by the reviewing IRB for his/her participation in the investigation. 
 
 
 
 
 
 
 
 
 
 
 
 
 
  

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By signing the study documents, the investigator agrees to conduct this study according 
to the obligations above and all other applicable regulatory and legal requirements. 
10. 
STUDY TIMELINE 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
.  
 
. 

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11. 
EXPERIMENTAL PLAN 
11.1 
OVERVIEW 
This study will be conducted in accordance with U.S. Code of Federal Regulations, the 
Declaration of Helsinki, ISO 14155:2011 and all other applicable laws and regulations.  
The study will not begin until regulatory and IRB approvals have been obtained. 
This study will be a prospective, multicenter, bilateral, non-randomized, open-label, 
comparative, 6-month clinical study conducted at up to 50 U.S. sites.  Subjects will be 
bilaterally implanted with Symfony lenses.  
 
 
 
 
  
 
 
Subjects will be examined postoperatively at 1 day, 1 week, 1 
month and 6 months following the second-eye surgery.  A 1-year examination will be 
required only if the subject reports any of the 3 bothersome visual symptom items of 
interest at the 6-month examination, or if the subject experiences an IOL repositioning 
procedure due to IOL misalignment during the study.   
Key preoperative data include ocular health and history, visual acuities, manifest 
refraction, keratometry, biomicroscopic slit-lamp findings, ocular symptoms and 
biometry.  The operative visit will include standard procedures for cataract surgery and 

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IOL implantation.  Key postoperative data collection includes non-directed visual 
symptoms, questionnaires, distance visual acuities, manifest refraction, keratometry, 
slit-lamp findings and adverse events.  A chart summary of all examination procedures 
required at each study visit is provided in Appendix A.   
11.2 
VISIT SCHEDULE 
The study visit schedule for all study subjects is outlined below in Table 4.  Additional 
visits may be conducted at the discretion of the investigator; however, routine follow-up 
visits without reports of ocular adverse event(s) or spontaneous reports of any of the 
3 bothersome visual symptom items of interest are not considered study visits and will 
not be reported in the study database.  
 
 
 
   
TABLE 4 
Study Visit Schedule 
Visit 
Exam 
1 
Preoperative Exam 
2 
Eye Surgery 
3 
1 day 
4 
1 week 
5 
d Eye Surgery 
6 
1 day 
7 
1 week 
8 
1 month 
9 
6 months 
10a 
1 yeara 
a  
 
 
 
. 
11.3 
PREOPERATIVE PROCEDURES 
Subjects will be considered eligible for treatment only after the current IRB-approved 
informed consent form is signed and all eligibility criteria are met.  The informed consent 
form must be signed before any study-specific examinations are performed, and this 
must be documented in the source documents.  An Authorization for Use/Disclosure of 
Health Information Form (HIPAA authorization) or similar medical treatment privacy law 
documentation must also be signed.    

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  Documentation (via the TECNIS Symfony Toric 
IOL calculator) of the toric power lens choice for each eye of each subject is required.   
Preoperative testing to be performed includes the following: 
 
Informed consent documentation  
 
Subject demographic information  
 
Ocular history, including presence of ocular pathology for each eye 
 
Potential best-corrected distance visual acuity for each eye (Note:  Snellen 20/30 
or better is recommended for study inclusion; may be performed by surgeon 
estimation) 
 
Monocular uncorrected distance visual acuity (Snellen) for each eye  
 
Monocular best corrected distance visual acuity (Snellen) for each eye 
 
Manifest refraction (Snellen) for each eye 
 
Keratometry for each eye by keratometer only (no Sim-K allowed) 
 
Intraocular pressure for each eye 
 
Ocular medications for each eye 
 
Cataract type and density for each eye 
 
Fundus exam for each eye (dilated with ophthalmoscopy or undilated with a 
wide-field retinal imaging system, e.g., Optomap.  The same method should be 
used for pre- and postoperative examinations) 
 
Medical and lens findings for each eye from a biomicroscopic slit-lamp exam  
 
Axial length, vertex distance, spherical equivalent IOL power and spherical 
equivalent targeted refraction (emmetropia, within ±0.50 D) for each eye using 
the investigator’s preferred biometry method (IOLMaster, LenStar, or ultrasound) 
 
A-constant or Surgeon Factor used for spherical equivalent IOL power 
determination for each eye  
 
Surgeon-estimated surgically-induced astigmatism (SIA) and planned incision 
location for each eye 
 
Documentation of the TECNIS Symfony Toric IOL calculator choice of ZXT toric 
power for each eye and corresponding residual refractive cylinder and axis, as 
well as documentation of inclusion of the optional posterior corneal astigmatism 
algorithm  

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 
PRVSQ Subject Questionnaire (Appendix B)  
LENS POWER CALCULATIONS AND IOL SELECTION:   
 
 
 
 
 
 
 
   
In order to verify subject eligibility and to optimize toric IOL selection and axis placement, 
investigators will use the web-based TECNIS Symfony Toric IOL calculator 
(www.TecnisToricCalc.com) to determine the appropriate IOL model for each eye.  Note 
that the TECNIS Symfony Toric IOL calculator provides toric IOL options based on 
predicted astigmatism, i.e., the vector sum of pre-existing corneal astigmatism and the 
expected effect of SIA.  For this study, subjects are to have corneal astigmatism in at 
least one eye that, when taking SIA into account and using the PCA algorithm, has 
approximately 2.00 D to 3.00 D (higher-cylinder group) or 1.00 D to 1.50 D 
(lower-cylinder group) of corneal astigmatism to be corrected, and subjects must qualify 
for implantation of the suitable toric IOL by the TECNIS Symfony Toric IOL calculator.  
 
 
 
 
Predicted residual refractive cylinder must be ≤0.50 D for all toric 
eyes.  For all subjects, the IOL model selections chosen by the investigator via the 
TECNIS Symfony Toric IOL calculator are to be printed and maintained as source 
documentation.   
 
 
 
 
11.4 
STUDY LENS SUPPLY  
 
 
.   

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11.5 
OPERATIVE PROCEDURES 
The investigator should use his or her standard, small-incision, cataract extraction 
surgical technique.  All lenses should be folded for implantation and inserted into the 
capsular bag using one of the JJSV-validated insertion systems.  
 
 
 
 
 
 
  If exited during the first-
eye surgery, the subject will be considered a screen failure.  
 
 
 
 
 
 
Following lens insertion, Symfony Toric IOLs are to be precisely aligned with the 
intended axis of placement using the imaginary line formed by the axis orientation marks 
at each of the haptic/optic junctions of the IOL, identifying the flat meridian of the optic.  
Special care should be taken to ensure proper positioning of the Symfony Toric IOL at 
the intended axis following viscoelastic removal and/or inflation of the capsular bag at 
the end of the surgical case.  All viscoelastic must be carefully removed from the 
capsular bag.  Residual viscoelastic and/or over-inflation of the bag may allow the lens 
to rotate, causing misalignment of the Symfony Toric IOL from the intended axis.    
Operative case report forms will collect the following information: 
 
Date of surgery 
 
Operative eye 
 
IOL model, power and serial number 
 
Use of intraoperative wavefront analysis 
 
Incision location  
 
Surgical complications  
 
Other surgical procedures 
 
IOL placement (e.g., within capsular bag, proper alignment, etc.) 
 
Wound closure (e.g., suture required) 
 
Adverse events 
11.6 
POSTOPERATIVE PROCEDURES 
Postoperatively, all subjects will be examined according to the schedule in Section 11.2, 
Visit Schedule.   

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Beginning with the 1-month visit, prior to any testing being performed at any follow-up 
visit, the subject will be asked how their vision has been since the last visit 
 
and the PRVSQ questionnaire will be administered.  
If a subject requires a lens repositioning procedure due to IOL misalignment at any time 
during the study, or if a subject reports a 
 visual symptom 
 at 6 months for any of the 3 items of 
interest (halos, glare or starbursts) contained in the PRVSQ, the subject will also 
undergo a visit at 1 year.   
1-Day Visit:  Postoperative procedures require a serious and/or device-related adverse 
event review.   
1-Week Visit:  Postoperative procedures require a serious and/or device-related 
adverse event review.   
1-Month Visit:  Postoperative procedures will include the non-directed subject question; 
administration of the PRVSQ questionnaire, distance visual acuities, manifest refraction, 
keratometry, intraocular pressure and biomicroscopic slit-lamp examination.  A spectacle 
and/or contact lens prescription will be offered to each subject.   
6-Month Visit: Postoperative procedures will include the non-directed subject question, 
administration of the PRVSQ questionnaire, manifest refraction, distance visual acuities, 
intraocular pressure, keratometry and a slit-lamp exam.  If the subject indicates a 
 
 visual symptom 
 
for any of the 3 items of interest (halos, glare or starbursts) contained in the PRVSQ, the 
subject will be required to return for a 1-year postoperative visit.  
1-Year Visit (if required): Postoperative procedures will include the non-directed 
subject question, administration of the PRVSQ questionnaire, manifest refraction, 
distance visual acuities, intraocular pressure, keratometry and a slit-lamp exam.  
If refractive correction is required during the study postoperatively, spectacles or contact 
lenses will be prescribed; however, no additional refractive enhancement procedures 
(LRI, AK, etc.) are allowed until after completion of the 6-month study visit.  
 
 
 
 
 
  
The postoperative case report form will collect the following information for scheduled 
study visits (see Section 11.7, Postoperative Procedures for information to be collected 
for unscheduled visits): 

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 
Confirmation of offering of spectacle and/or contact lens prescription: 1-month 
visit only 
 
Non-directed subject question responses at every visit.   
 
PRVSQ questionnaire: 1-month, 6-month and 1-year visits.  Following completion 
of the questionnaire by the subject, the questionnaire is to be reviewed by the 
site personnel for reports of very or extremely bothersome visual symptoms of 
interest (halos, glare or starbursts) that impact daily living under overall 
conditions. 
 
Keratometry: 1-month, 6-month and 1-year visits 
 
Monocular uncorrected distance visual acuity at 4 m (Snellen or ETDRS): 
1-month, 6-month and 1-year visits  
 
Manifest refraction (Snellen or ETDRS): 1-month, 6-month and 1-year visits; 
manifest refraction is to be performed using the Maximum Plus refraction method 
as detailed in Appendix C.  
 
Monocular best corrected distance visual acuity at 4 m (Snellen or ETDRS): 
1-month, 6-month and 1-year visits  
 
Medical and lens findings from biomicroscopic slit-lamp exam: 1-month, 6-month 
and 1-year visits; findings of aqueous cells and flare, corneal edema, posterior 
capsule striae, posterior capsular opacification and IOL glistenings are to be 
rated using standardized grading scales provided in Appendix D.   
 
Ocular medications: In the event of a serious and/or device-related adverse 
event.   
 
Intraocular pressure: 1-month, 6-month and 1-year visits   
 
Fundus exam, if medically indicated  
 
Occurrence of Nd:YAG capsulotomy(ies) 
 
Occurrence of any adverse events 
11.7 
UNSCHEDULED VISITS 
A visit is considered an unscheduled study visit when it occurs other than at the 
specified 1-day, 1-week, 1-month or 6-month study visits AND at which a serious or 
device-related adverse event is reported OR if the subject has a spontaneous report of 
any of the 3 visual symptom items of interest (halos, glare or starbursts) after the 
1 month postoperative visit.  
 
 
 
 
 
 
.   
Testing to be performed at an unscheduled visit due to a serious or device-related 
adverse event is at the discretion of the Investigator.  If the event results in an IOL 

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repositioning procedure (secondary surgical procedure), keratometry is to be performed 
and the PRVSQ questionnaire is to be administered PRIOR to the IOL repositioning.   
At any unscheduled visit where the subject spontaneously reports any of the 3 visual 
symptom items of interest (halos, glare or starbursts), the PRVSQ questionnaire is to be 
administered.   
Following completion of a PRVSQ questionnaire by the subject, the questionnaire is to 
be reviewed by the site personnel 
 
 
. 
At any unscheduled visit where any of the 3 
 visual 
symptom items of interest 
 are reported via PRVSQ to impact 
daily living under overall conditions, monocular distance visual acuities, manifest 
refraction, keratometry and biomicroscopic slit-lamp examinations will be performed.    
Data to be collected on unscheduled visit forms include: 
 
Serious or device-related adverse event, date of onset, classification, prognosis 
and treatment 
 
Non-directed subject question 
 
PRVSQ questionnaire - in the event of a spontaneous report of any of the 3 
visual symptoms of interest (
) or prior to an IOL 
repositioning procedure 
 
Manifest refraction (Snellen or ETDRS) - if a serious or device-related event 
occurs or if any of the 3 visual symptom items of interest 
 
 
 are reported via PRVSQ 
 
Uncorrected and best-corrected monocular distance visual acuity (Snellen or 
ETDRS) - if a serious or device-related event occurs or if any of the 
 
visual symptom items of interest 
 
 are reported via 
PRVSQ 
 
Keratometry - if a serious or device-related event occurs or if any of the 
 
visual symptom items of interest (
 
 reported via 
PRVSQ 
 
Slit-lamp examination – findings of aqueous cells and flare, corneal edema, 
posterior capsule striae, posterior capsular opacification and IOL glistenings are 
to be rated using standardized grading scales provided in Appendix D.  
 
Fundus exam, if performed 
 
Ocular medications - if a serious or device-related event occurs 

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11.8 
EXIT OF SUBJECTS  
An Exit Case Report Form will be completed for all subjects, either when they complete 
the study or if they exit early.   
It is the responsibility of the investigator to provide complete follow-up data to JJSV for 
each subject, and every attempt will be made to gather that complete follow-up data for 
all subjects enrolled as missing data can have a negative effect on the study results. 
Patients who would be traveling, relocating or otherwise unavailable for postoperative 
follow-up visits should not be chosen for this clinical study. 
SUBJECT FOLLOW-UP 
To minimize subjects lost to follow-up, compensation will be provided for the subject’s 
time and participation in the study at the 1- and 6-month postoperative exams, as well as 
the 1-year visit, if required.  Additionally, sites will be compensated for completion of the 
1-day, 1-week, 1- and 6-month exams as well as the 1-year visit, if required.  Sites will 
be provided frequent listings of upcoming 1-month, 6-month and 1-year visits.  It is 
anticipated that at least 95% of implanted subjects will be available for the 6-month study 
visit (i.e., no more than a 5% lost-to-follow-up rate at 6 months postoperatively).  
 
 
 
 
 
   
SUBJECT EARLY EXIT 
Subjects will be discontinued from the study if the study lens is removed or if the subject 
dies.  Subjects will be considered “lost-to-follow-up” from the study only if irretrievably 
lost for unavoidable reasons (e.g., subject moved/unable to locate, subject 
uncooperative/refuses further study participation, subject ill/unable to travel).
 
 
 
If a subject is exited from the study, the investigator will, if at all 
possible, have the subject return for a final study visit.   
If a subject is exited early from the study, the investigator will complete an Exit Case 
Report Form indicating the reason for study exit.  In the event of a lens removal or other 
serious adverse event, the subject may be exited from the study; however, effort should 
be made by the investigator to follow the subject until resolution of the adverse event.  In 
this situation, additional information will be documented in the SAE/ADE form, not on an 
Unscheduled Visit form. 

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Following study completion or early exit, all study subjects are to be instructed to 
undergo regular eye examinations at least yearly and also to return to their doctor if any 
eye complications are experienced in the interim.   
 
 
 
 
 
 
 
 
 
   
11.9 
PROTOCOL DEVIATIONS  
Any departure from the protocol procedures represents a protocol deviation.  Protocol 
deviations may be subject-based (e.g., inclusion/exclusion criteria, informed consent 
deviation, etc.) or procedural-based (e.g., out-of-interval visits, non-compliance with 
testing procedures, etc.).  All protocol deviations will be documented using protocol 
deviation case report forms.   
Any deviation made to protect the life or physical well-being of a subject in an 
emergency, as well as any use of a study device without obtaining informed consent, 
must be reported to JJSV within 5 working days. Protocol deviations will be monitored by 
JJSV, and if the non-compliance is persistent or egregious, JJSV may take action, 
including but not limited to termination of the investigator’s participation in the study.  
The investigator is also responsible for informing the reviewing IRB of instances of 
protocol non-compliance in accordance with the IRB requirements. 
12. 
ADVERSE EVENTS AND PRODUCT COMPLAINTS 
12.1  ADVERSE EVENT AND COMPLAINT DEFINITIONS 
Adverse Event (AE) 
An adverse event is defined (following ISO 14155) as any untoward medical occurrence, 
unintended disease or injury, or untoward clinical signs (including abnormal laboratory 
findings) in subjects, users or other persons, whether or not related to the study device.  
All adverse events will be recorded in the subject’s case report forms.   
NOTE: Findings typical of early postoperative healing (e.g., corneal edema, cells and 
flare, elevated intraocular pressure, etc.) will not be considered an ocular adverse event 
in the first postoperative month.   

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Serious Adverse Event (SAE) 
An adverse event is considered serious (following ISO 14155) if it is an untoward 
occurrence which may or may not be related to use of the study device that 
 
is sight- or life-threatening,  
 
results in death,  
 
requires in-patient hospitalization or prolongation of hospitalization (a planned 
hospitalization for a pre-existing condition without a serious deterioration in 
health is not considered a serious adverse event), 
 
results in permanent impairment of a body structure or body function,  
 
necessitates medical or surgical intervention to prevent permanent impairment to 
a body structure or function, or 
 
results in fetal distress, fetal death or a congenital abnormality or birth defect 
A Serious Adverse Event/Adverse Device Effect (SAE/ADE) form will be completed by 
the investigative site for any SAE. 
Device-Related Adverse Event/Adverse Device Effect (ADE) 
A device-related adverse event is defined as any adverse event that is believed to be 
definitely, probably or possibly related to the study device (following the guidelines in 
Section 12.4, Causal Relationship).  A device-related event is also considered an 
adverse device effect (ADE; following ISO 14155) resulting from the use of the study 
device that may result from user error, insufficiencies or inadequacies in the instructions 
for use, deployment, implantation, installation, operation of any malfunction of the 
device.   
An SAE/ADE form will be completed by the investigative site for any ADE. 
Study-Specific Serious Anticipated Adverse Events 
The following is a list including, but not limited to, ocular adverse events that are 
anticipated and must be reported to JJSV for this study.  Any events that are unlikely but 
anticipated (i.e., endophthalmitis) will be reported to the FDA. 
 
Endophthalmitis/Intraocular infection 
 
Hypopyon 
 
Hyphema 
 
Lens dislocation 
 
Cystoid macular edema  
 
Mechanical pupillary block 
 
Rhegmatogenous retinal detachment/tear 
 
Persistent corneal edema  
 
Persistent iritis/uveitis  
 
Toxic anterior segment syndrome (TASS) 
 
Persistent elevated IOP requiring treatment  

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 
Tilt, decentration, residual refractive error or axis misalignment resulting in 
secondary surgical intervention (e.g., repositioning) 
 
Visual symptoms requiring secondary surgical intervention  
 
Residual refractive error resulting in a secondary surgical intervention 
 
Residual lens remnants resulting in a secondary surgical intervention 
 
 
   
 
 
 
   
 
 
 
 
 
 
 
  
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse 
Device Effect (USADE) 
Any UADE (USA 21CFR 812.3(s)) or USADE (ISO 14155) is defined as any serious 
adverse effect on health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death was not previously identified in 
nature, severity, or degree of incidence in the investigational plan (i.e., this protocol), 
application (including a supplementary plan or application), or risk assessment, or any 
other unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects. 
An SAE/ADE form will be completed by the investigative site for any UADE or USADE. 
12.2 
PRODUCT COMPLAINT/DEVICE DEFICIENCY DEFINITION 
A product complaint/device deficiency is defined (21 CFR 820.3(b) and ISO 14155) as 
any alleged deficiency related to the identity, quality, durability, reliability, safety, 
effectiveness, or performance of a device.  Product complaints can pertain to any 
marketed JJSV device being used in the study.  The investigator is to assess whether 
the deficiency could have led to a serious adverse event without suitable action or 
intervention or under less fortunate circumstances. 

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12.3  ADVERSE EVENT AND COMPLAINT REPORTING REQUIREMENTS 
All adverse events and any complaint encountered using any JJSV product, regardless 
of severity and whether or not attributed to the IOLs used in this study, are to be 
reported to JJSV and recorded on the case report form corresponding to the visit during 
which awareness of the event occurred.  Adverse events are also to be reported to the 
reviewing IRB as per the IRB’s reporting requirements.  If required, adverse events will 
be reported to the appropriate regulatory agencies (e.g., FDA) according to all applicable 
laws and regulations.   
All serious adverse events, whether anticipated or unanticipated, all adverse device 
effects and all device complaints, deficiencies or malfunctions with or without an adverse 
event, shall be reported per the USA Code of Federal Regulations (21CFR812) for sites 
in the USA as follows: 
Adverse Event Reporting 
An adverse event that is not serious or device-related is to be reported to JJSV in a 
timely manner.  Notification of non-serious and non-device related adverse events will 
occur by recording events on the CRF when noted.  Such adverse events are also to be 
reported to the reviewing IRB per their reporting requirements.  
Serious and/or Device-Related Adverse Event Reporting 
SAE’s and/or ADEs are to be documented using the Serious Adverse Event/Adverse 
Device Effect (SAE/ADE) CRF.  In the event of an SAE, JJSV must be notified 
immediately (no later than 24 hours after detection).  Any SAE/ADE is to be reported by 
phone, email and/or by submitting a completed SAE/ADE CRF.  Any SAE or device-
related AE should also be reported to the investigator’s IRB per their reporting 
requirements. 
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse 
Device Effect (USADE) Reporting 
If during the study, a serious adverse event occurs that may reasonably be regarded as 
study-device-related and was not previously expected in nature, severity, or degree of 
incidence, the investigator is to report the UADE/USADE to JJSV within 24 hours, and to 
the investigator’s IRB as soon as possible.  Any UADE or USADE is to be reported by 
phone, email and/or submitting a completed SAE/ADE CRF.   
Complaints/Device Deficiency Reporting  
A general product complaint or device deficiency is to be reported to JJSV in a timely 
manner.  Notification of complaints/device deficiencies will occur by either recording 
complaints on the “Complaint Form” CRF and/or by contacting the sponsor.  

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Any device deficiency that could have led to a serious adverse event without suitable 
action or intervention, or under less fortunate circumstances, must be reported to the 
sponsor immediately (no later than 24 hours after detection). Device deficiencies that 
could have led to a serious adverse event should also be reported to the investigator’s 
IRB per their reporting requirements. 
12.4  CAUSAL RELATIONSHIP 
The investigator should always be alert to adverse events that may be related to the 
study device or the use of the study device (i.e., the procedure specific to the initial 
application of the device).  An attempt should be made in every case to determine the 
causality of the event.  The following definitions are to be used as guidelines in 
determining the relationship between the event and the study device and/or use of the 
device.   
Definitely related: 
If the event is associated with the device and/or the use of the 
device beyond a reasonable doubt, a causal relationship exists 
between the adverse event and the device and/or the use of the 
study device. 
Probably related:   
There is a reasonable possibility of a causal relationship 
between the adverse event and the device and/or the use of the 
study device and/or the adverse event cannot be reasonably 
explained by another cause. 
Possibly related:   
The adverse event has not been determined to be related to the 
device or the use of the device, but no other cause has been 
identified and the device and/or the use of the study device 
cannot be ruled out as a possible cause. 
Unlikely to be related: The possibility of a potential causal relationship between 
adverse event and the device and/or the use of the device could 
exist, but the adverse event can be reasonably explained by 
another cause. 
Not related: 
There is no possibility of a causal relationship between the 
adverse event and the device and/or the use of the study device 
and/or the adverse event can be attributed to another cause. 
If an adverse event is believed to be definitely, probably or possibly related to the study 
device and/or the use of the device, the event will be considered related to the study 
device and/or the use of the device.    
12.5  ADVERSE EVENT FOLLOW-UP 
For every serious or device-related adverse event, appropriate measures should be 
undertaken to treat and/or monitor the subject until resolution occurs.  Obtain and 
maintain in the subject's files all pertinent medical data relating to the event including the 
subject’s medical records and medical reports and/or judgments from colleagues or 
outside specialists who assisted in the treatment and follow-up of the subject.  The 

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investigator should keep JJSV closely informed as to the outcome of serious and/or 
device-related adverse events, thereby allowing JJSV to comply with the appropriate 
regulatory reporting requirements.  The SAE/ADE CRF within the electronic data capture 
system should be updated as needed each time the subject returns to the investigator or 
other specialist(s) for follow-up of serious and/or device-related adverse event until 
resolution of the event.  Any subject who is exited from the study due to a serious and/or 
device-related adverse event will be followed until the outcome is determined. 
13. 
PROTOCOL CHANGES AND PROCEDURES 
If the investigator desires to modify any procedure and/or the design of the study, he or 
she must contact and obtain consent from JJSV regarding the proposed changes prior to 
implementation.  Any modifications (including additional data collection) require approval 
by the FDA and all other appropriate regulatory agencies, as well as approval of the 
governing IRBs prior to implementation.   
14. 
ETHICS REVIEW AND PATIENT WELFARE 
14.1 
INSTITUTIONAL REVIEW BOARD (IRB) 
It is the responsibility of the investigator to obtain prospective approval of the study 
protocol, protocol amendments or changes, informed consent forms and other relevant 
documents (e.g., advertisements) from the IRB.  All correspondence with the IRB should 
be retained in the Investigator Notebook.  Copies of IRB submissions and approvals 
should be forwarded to JJSV. 
The investigator is responsible for notifying the IRB of reportable adverse events as well 
as any other circumstance in which additional procedures outside the protocol were 
conducted to eliminate apparent hazards to subjects. 
14.2 
INFORMED CONSENT 
The current version of the IRB-approved study informed consent form must be signed 
and dated by each study subject prior to any study-specific examinations being 
performed.  The approved informed consent form is to be signed and dated by the 
subject as well as by the person who conducted the informed consent discussion.  The 
signed informed consent form will be maintained by the investigator as a permanent part 
of the subject’s medical records.  A signed and dated copy is to be provided to the 
subject.  
 
 
 
 
   

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Note: The informed consent process also includes obtaining the subject’s signature on 
an Authorization for Use/Disclosure of Health Information for Research Form.   
 
 
15. 
DOCUMENTATION 
15.1 
SOURCE DOCUMENTS 
Source documents must be kept for all study subjects.  Source documents may include 
a subject’s medical records, hospital charts, clinic charts, the investigator’s subject study 
files, as well as results of any diagnostic tests or procedures such as topographies or 
laboratory tests with photographs or instrument printouts. 
Each site is expected to adhere to the clinic’s own standard documentation requirements 
for medical charts/clinic notes.  However, for the purposes of this clinical study, the 
medical charts/clinic notes must also include, at a minimum, the following data that will 
be considered source data and will be reviewed by JJSV: 
 
Subject’s name and study identification number 
 
Subject’s contact information 
 
Study protocol number and the Sponsor name (JJSV) 
 
A statement that informed consent was obtained prior to participation in the study 
(including the date)  
 
Dates of all subject visits and surgeries throughout the duration of the study 
 
Implant serial number identification  
 
Concurrent medications 
 
Corrected and uncorrected distance visual acuity, if done  
 
Manifest refraction, if done 
 
Occurrence and status of any operative complications, postoperative medical or 
lens findings and adverse events 
 
Occurrence and status of any subject complaints, e.g., ocular/visual symptoms  
 
The date the subject exited the study, and a notation as to whether the subject 
completed the study or reason for early exit. 
15.2 
SUBJECT CONFIDENTIALITY 
Subjects will be assigned a site/subject number to maintain subject confidentiality.  
Subject names may possibly be disclosed to JJSV or regulatory agencies during 
inspection of medical records related to the study, but reasonable precautions will be 
taken to maintain confidentiality of personal information to the extent permitted by 
applicable laws and regulations. 

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15.3 
CASE REPORT FORM COMPLETION 
This study will use an electronic data capture system using electronic case report forms.  
Case report forms will be completed in accordance with instructions provided to the site 
prior to study start.  The investigator is responsible for ensuring that data are properly 
recorded in each subject’s electronic case report forms and related documents.  Prior to 
database lock, the investigator will verify completeness and accuracy of data submitted 
to JJSV.  
15.4 
STUDY SUMMARY 
A final investigator’s summary will be provided to JJSV and the reviewing IRB within 
3 months after termination or the completion of the study or the investigator’s part of the 
investigation. 
16. 
MONITORING 
 
. 
16.1 
DATA MONITORING 
In order to ensure a well-controlled clinical trial, JJSV will follow specific data monitoring 
procedures.  
 
 
   
 
 
 
 
 
 
Prevention of Missing Data 
Methods used to safeguard against missing data that can have deleterious effects on the 
study integrity and reliability of its outcomes will include training study staff 
 
In addition, subjects will be encouraged at the time of informed 
consent to avoid missing study visits, as missing data may affect the study reliability and 
diminish the scientific value of their contribution to the study. 
16.2 
ADMINISTRATIVE MONITORING 
Administrative monitoring procedures will ensure that subjects and case report forms 
can be traced and will allow monitoring of investigator progress and compliance.   

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Device Accountability 
As the study IOLs are commercially available, supply records for the lenses will solely be 
the responsibility of the site and managed by their customary methods.
 
 
 
Site Monitoring Plan 
 
 
 
 
 
   
 
 
 
 
 
 
   
 
 
 
 
   
 
  
 
 
16.3 
MEDICAL OVERSIGHT 
The medical monitor will be available throughout the clinical trial to review study results 
and to answer any questions from investigators. The medical monitor will review and 
assess any reports of serious and/or device-related adverse events and discuss these 
with the reporting investigator(s) as necessary. The medical monitor, as well as any 
other qualified personnel designated by JJSV, shall also review study reports. 

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17. 
PUBLICATIONS 
 
18. 
RISK ANALYSIS 
POTENTIAL RISKS AND RISK MANAGEMENT 
RISKS OF THE SYMFONY TORIC IOLS 
The Symfony Toric IOLs are intended to compensate for corneal astigmatism and to 
mitigate the effects of presbyopia and provide a continuous range of high-quality vision 
by extending the depth of focus.  Compared to an aspheric monofocal IOL, the lens 
provides improved intermediate and near visual acuity, while maintaining comparable 
distance visual acuity; however, glasses may still be needed to improve distance vision 
and/or to have useful vision for intermediate or near tasks.  The Symfony Toric IOLs may 
cause a reduction in contrast sensitivity under certain conditions, compared to an 
aspheric monofocal IOL.  Some visual effects associated with the Symfony Toric IOL 
may be expected due to the lens design that delivers elongation of focus. These may 
include a perception of halos, glare, or starbursts around lights under nighttime 
conditions.  In addition, rotation of the Symfony Toric IOL away from its intended axis 
can reduce its astigmatic correction.  Misalignment greater than 30° may increase 
postoperative refractive cylinder.  If necessary, lens repositioning should occur as early 
as possible prior to lens encapsulation. These risks are not unlike other lenses of this 
kind.   
GENERAL RISKS OF CATARACT SURGERY AND IOL IMPLANTATION 
There are risks and complications associated with cataract surgery and IOL implantation 
in general.  These can include worsening of vision, hemorrhage, loss of corneal clarity, 
inflammation, infections, retinal detachment, pupil changes, glaucoma, etc.  
Complications can result in poor vision, loss of vision or loss of the eye.   
RISK MANAGEMENT 
Subjects will be closely monitored thought the trial duration.  The occurrence of adverse 
events and complaints will be assessed at each study visit and reported to JJSV 
according to Section 12, Adverse Events and Product Complaints.  Additionally, JJSV 
will monitor incoming data following the procedures outlined in Section 16, Monitoring.  
The Medical Monitor will ensure subjects are not exposed to additional risks by 
monitoring serious adverse events, device-related adverse events, and 
device-deficiencies that could have led to serious adverse events (Section 16.3, 
Medical Oversight).  

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POTENTIAL BENEFITS 
The clinical performance of the Symfony Toric IOL, Models ZXT150, ZXT300 and 
ZXT375, is expected to be similar to the non-toric Symfony IOL, Model ZXR00 (USA 
FDA approval P980040/S065), with respect to mitigating the effects of presbyopia by 
providing an extended depth of focus.  Compared to an aspheric monofocal IOL, the 
lens is expected to provide improved intermediate and near visual acuity, while 
maintaining comparable distance visual acuity.  In addition, the Symfony Toric IOLs are 
expected to be similar to the TECNIS Toric Model Series ZCT IOLs (USA FDA approval 
P980040/039) for reduction in residual refractive cylinder.  
CONCLUSION 
The hazards/risks associated with the Symfony Toric IOL, Models ZXT150, ZXT300 and 
ZXT375, are acceptable and within those of JJSV’s other advanced optic IOLs.  The 
potential clinical benefits of these lenses outweigh the residual risks when the device is 
used as intended. 
19. 
RECORD RETENTION 
All study-related correspondence, subject records, consent forms, Authorization for 
Use/Disclosure of Health Information Forms or similar medical treatment privacy law 
documentation, records of the distribution and use of all study products, and an 
electronic copy of the completed case report forms should be maintained by the 
investigator.   
 
   
 
 
 
 
 
All case report forms 
 
All adverse event information (adverse event forms, follow-up letters, etc.) 
 
IRB and regulatory approval documentation 
 
Study correspondence  
 
Study agreements 
 
Site visit documentation 
 
Protocol(s) and the reason for any deviations from the protocol 
 
Subject log(s) 
 
Directions for Use 
 
Completed subject informed consent forms and medical privacy forms (e.g., 
Authorization for Use/Disclosure of Health Information or equivalent 

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documentation necessary to comply with applicable privacy laws pertaining to 
medical treatment in the governing countries) 
 
Subject medical chart/clinic notes 
20. 
TERMINATION OF THE INVESTIGATION 
The clinical investigation will be suspended in the event that high levels of complications 
and/or adverse events occur that are unexpected in nature and/or severity and are 
possibly related to use of the study device.  The clinical investigation may be suspended 
if the Medical Monitor or IRB, upon review and evaluation of the clinical data, finds 
unacceptable clinical performance or the level of single or total complications and/or 
adverse events unacceptable for continuation of the investigation. 
If causality is shown not to be related to the study device, the study may be resumed in 
accordance with the IRB and regulations of the FDA. The study will be terminated if 
causality is shown to be related to the study device. 
Additionally, the investigator or JJSV may stop a subject’s participation at any time.  
JJSV may also stop the study at any time for reasons it determines appropriate.  
However, no suspension of the study would be made to disadvantage the study 
subjects.  Following suspension of the study for any reason, all study subjects who have 
already received treatment should continue to be followed through completion of the 
study visit schedule. 
21. 
STATISTICAL METHODS  
This section highlights the analyses to be performed for key study endpoints.  The 
6-month postoperative visit is the critical analysis time point for all endpoints.  Outcomes 
for subjects implanted with the higher-cylinder IOLs (ZXT300 and ZXT375) and the 
lower-cylinder control lens (ZXT150) will be reported separately.  Descriptive statistics 
will typically include mean, standard deviation, minimum, maximum for continuous data 
with frequency and proportion reported for categorical data.   
21.1 
ANALYSIS POPULATION 
For the primary endpoint, the primary analysis population will be all bilaterally-implanted 
subjects having available data at the 6-month visit, with data reported separately for the 
higher- and lower-cylinder groups.  Data will also be reported for all subjects, including 
bilateral subjects and those with only one eye implanted (having a phakic lens, a 
cataract or other IOL in the fellow eye).  
 
 
 
.  
 
 

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In addition to the primary population analyses discussed above, additional analyses will 
also be performed for the primary endpoint to evaluate the 
 
at the six-month visit who did not undergo repositioning or IOL removal.  
 
 
For other questionnaire items, bilaterally-implanted subjects with data at six months 
postoperative will be used for analysis.  Refraction, monocular visual acuity, 
medical/lens findings and adverse event data will be reported for primary eyes (first eye 
implanted) and fellow eyes.  Data will be reported separately for the higher-cylinder 
group (ZXT300, ZXT375) and the lower-cylinder control eyes (ZXT150).   
21.2 
PRIMARY ENDPOINT 
The primary endpoints are the rate of bothersome visual symptoms and the rate of 
reported difficulty with an activity due to visual symptoms at 6 months postoperative.  
 
  
 
 
 
 
 
 
The first primary endpoint is the rate of bothersome visual symptoms, 
 
 
.  The second primary endpoint is the rate of 
reported difficulty with an activity due to one or more visual symptoms, determined by a 
“Yes” response to the question “Is there anything you have a lot of difficulty with, or do 
not do, because of [visual symptom]”) at 6 months postoperative.   
The frequency and proportion of subjects with bothersome visual symptoms for one or 
more visual symptoms, and the frequency and proportion of subjects reporting difficulty 
with an activity due to one or more visual symptoms will be reported along with the two-
sided, 95% confidence interval at the 6-month visit.   
Justification of Effect Size:   
Using an assumed value of 20% for bothersome visual symptoms or difficulty with an 
activity due to visual symptoms, and a sample size of 240 evaluable subjects per group, 
a two-sided 95% confidence interval will estimate the observed rate of bothersome 
visual symptoms to within 4.2 percentage points.  

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21.3 
ADDITIONAL ENDPOINTS 
The frequency and proportion of subjects with each response will be reported for the 
individual visual symptom items for overall and with and without correction.   
The frequency and proportion achieving each acuity level will be reported for monocular 
visual acuity.   
Descriptive statistics will be reported for mean percent reduction in cylinder, refractive 
cylinder, cylinder vs preoperatively-predicted cylinder, spherical equivalent and spherical 
equivalent vs preoperatively-predicted spherical equivalent.  The frequency and 
proportion of eyes within 0.50 D and within 1.00 D of the preoperatively-predicted values 
will be reported for refractive cylinder and spherical equivalent.  Percent reduction in 
cylinder will be calculated for each eye using the following formula:   
100*((Postop Ref. Cyl. - Preop K. Cyl.)/(Target Ref. Cyl. - Preop K. Cyl. )) 
 Key: Ref. Cyl.=absolute refractive cylinder; K. Cyl.=keratometric cylinder;  
Refractive data will be referred to the corneal plane prior to determining percent 
reduction in cylinder. 
Enrollment data, demographic data, subject accountability data and operative 
complications/procedures will be reported using descriptive statistics.  Visual symptom 
findings, adverse events and other key data will be reported at 1 year for subjects who 
experienced a repositioning procedure during the study or who were reported with 
bothersome visual symptoms at the 6-month visit.  
The frequency and proportion of primary and fellow eyes with medical/lens findings will 
also be reported.  In addition, rates of IOL repositioning procedures (secondary surgical 
intervention) due to IOL misalignment, rates of explants related to visual symptoms, 
rates of refractive procedures performed during the study period, and other adverse 
events will be reported. 
21.4 
INTERIM REPORTS 
 
 
 
 
 
 
   
 
 

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21.5 
SAMPLE SIZE CALCULATIONS 
With a sample size of 240 subjects and assuming a 20% rate of bothersome visual 
symptoms or difficulty with an activity due to visual symptoms, a two-sided 95% 
confidence interval will estimate the observed rate of bothersome visual symptoms to 
within 4.2 percentage points.  
To achieve 240 higher-cylinder group subjects and 240 lower-cylinder group subjects 
evaluable at 6 months, assuming an initial 20% screen-fail rate and a 5% lost-to-follow-
up rate, up to 634 total subjects will be enrolled. 
22. 
REFERENCES 
1. 
 
 
 
 
 
 
 
 

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APPENDIX A - SUMMARY OF EXAMINATIONS FOR EACH VISIT 

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APPENDIX B - PATIENT-REPORTED VISUAL SYMPTOMS QUESTIONNAIRE 
(PRVSQ V2) 
 

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________________________________________________________________________ 
 
 
 
Patient Reported 
Visual Symptoms  
Questionnaire 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX C - MAXIMUM
 
  
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 

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APPENDIX D - SLIT-LAMP EXAM RATINGS 
 
 
 
 
 
 
CELLS 
Grade 
Cells in Field (Field is a 1x1 mm slit beam) 
0 
<1 
0.5+ 
1 - 5 
1+ 
6 - 15 
2+ 
16 - 25 
3+ 
26 - 50 
4+ 
>50 
 
FLARE 
Grade 
Description 
0 
None 
1+ 
Faint 
2+ 
Moderate (iris and lens details clear) 
3+ 
Marked (iris and lens details hazy) 
4+ 
Intense (fibrin or plastic aqueous) 
B.  Ratings of Corneal Edema 
Corneal edema should be classified according to the haziness of the epithelium, the number of 
microcysts observed, and the clouding of the stroma. 
Amount 
Grade 
Description 
None 
0 
Normal transparency: 
a. No epithelial or sub-epithelial haziness 
b. No microcysts 
c. 
No stromal cloudiness 
Trace 
+1 
a. Barely discernible localized epithelial or sub-epithelial haziness, and/or 
b. 1 to 20 microcysts, and/or 
c. Barely discernible localized stromal cloudiness 
Mild 
+2 
a. Faint but definite localized or generalized epithelial, sub-epithelial or 
stromal haziness/cloudiness, and/or 
b. 21-50 microcysts 
Moderate 
+3 
a. Significant localized or generalized epithelial, sub-epithelial or stromal 
haziness/cloudiness and/or 
b. 51-100 microcysts 
Severe 
+4 
a. Definite widespread epithelial or stromal cloudiness, giving dull glass 
appearance to cornea or numerous coalescent bullae (please note the 
number and location of bullae), and/or 
b. >100 microcysts or bullae, and/or 
c. Numerous striae (please note the number and location of striae or folds) 

JOHNSON & JOHNSON SURGICAL VISION, INC. 
CONFIDENTIAL 
Version 5.0 
54 
PR/TIOL-205-STPA 
C.  Posterior Capsule Striae Grading Scale 
The following five-point grading scale is to be used for rating striae in the posterior capsule: 
Amount 
Grade 
Description 
None 
0 
None 
Trace 
+1 
One detectable, barely noticeable striae 
Mild 
+2 
One or two prominent striae 
Moderate 
+3 
Three or more prominent striae, but visibility of retina is 
not impacted 
Severe 
+4 
Three or more prominent striae affecting visualization of 
retina 
 
D.  Posterior Capsule Opacification Grading Scale 
Below is the five-point grading scale to be used for PCO determination: 
Amount 
Grade 
Description 
None 
0 
Normal posterior capsule with no area of opacity.  Red reflex 
bright. 
Trace 
+1 
Some loss of transparency involving the posterior capsule.  
Red reflex fairly bright 
Mild 
+2 
Mild loss of transparency with cloudiness extending through 
most of the posterior capsule.  There may be a few Elschnig’s 
pearls in the posterior capsule.  Red reflex mildly diminished. 
Moderate 
+3 
Moderate loss of transparency with difficulty visualizing the 
retina.  There may be multiple Elschnig’s pearls in the 
posterior capsule.  Red reflex markedly diminished. 
Severe 
+4 
Posterior capsule very opaque with inability to view the retina.  
The posterior capsule may have confluent Elschnig’s pearls 
and fibrous scarring.  Red reflex barely visible. 
 
E.  IOL Glistenings  
Use the following scale to grade IOL glistenings, using a slit beam 2.0 mm wide and 10.0 mm 
long: 
Amount 
Grade 
Description 
None 
0 
No glistenings visible 
Rare 
+0.5 
<10 glistenings visible 
Trace 
+1 
10-19 glistenings visible 
Mild 
+2 
20-29 glistenings visible 
Moderate 
+3 
30-39 glistenings visible 
Severe 
+4 
≥ 40 glistenings visible