Study Protocol

Clinical Investigation of the Safety and Effectiveness of the

Next-Generation TECNIS® Symfony® Intraocular Lens Model ZHR00

NCT Number: NCT03500198

Version 4.0

Document date: 01 Apr 2019

Halos are bright circles or rings that appear around a source of light. Halos may occur when looking at an oncoming automobile’s headlights or street lights at night.

Starbursts are one or more lines or rays that surround or appear from a source of light. Starbursts may occur when looking at an oncoming automobile’s headlights or street lights at night.

Multiple or double vision is when objects appear as two separate or overlapping images. Multiple or double vision may occur when looking at words in a book or on a street sign.

Sensitivity to light is a decreased ability to tolerate light, such as sunlight, fluorescent light or incandescent light. Sensitivity to light may occur in a brightly lit grocery or department store.

Glare related to scattered light decreases the ability to distinguish differences between objects and their background. Glare related to scattered light may occur when looking at an oncoming automobile’s headlights at night.

Occlusions are fixed dark or light blocked areas within your vision. Occlusions are constant and do not come and go.

Poor low light vision is having decreased clarity of vision in twilight or dusk conditions. Poor low light vision may occur when reading a restaurant menu in low light.

The following questions ask about your vision DURING THE LAST 7 DAYS.

Please read each question carefully and answer as honestly as you can without the help of anyone.

Yes No

a Distance vision (more than 5 feet away) ......................................................... 1 ............. 2 b Intermediate vision (1.5 to 5 feet away) ........................................................ 1 ............. 2 c Near vision (less than 1.5 feet away) .............................................................. 1 .............. 2

2.

All of the time

Most of the time

Some of the time

A little of the time

None of the time

a Distance vision (more than 5 feet away) ........... 1 ......... 2 ......... 3 ......... 4 ......... 5 b Intermediate vision (1.5 to 5 feet away) ........... 1 ......... 2 ......... 3 ......... 4 ......... 5 c Near vision (less than 1.5 feet away) ................ 1 ......... 2 ......... 3 ......... 4 ......... 5

d Overall vision (all distances) .............................. 1 ......... 2 ......... 3 ......... 4 ......... 5

3.

All of the time

Most of the time

Some of the time

A little of the time

None of the time

a Distance vision (more than 5 feet away) ........... 1 ......... 2 ......... 3 ......... 4 ......... 5 b Intermediate vision (1.5 to 5 feet away) ........... 1 ......... 2 ......... 3 ......... 4 ......... 5 c Near vision (less than 1.5 feet away) ................ 1 ......... 2 ......... 3 ......... 4 ......... 5

d Overall vision (all distances) .............................. 1 ......... 2 ......... 3 ......... 4 ......... 5

4.