Safety and Effectiveness of the CustomFlex Artificial Iris Prosthesis for the Treatment of Iris Defects

Inclusion Criteria:

1. 22 years of age or older

2. Having a diagnosis of congenital or acquired full or partial iris defect in the study
eye.

3. Having symptoms of light sensitivity, photophobia, and/or glare in the study eye.

4. Subjects should be pseudophakic, aphakic or require cataract extraction.

5. Signed and received a copy of the signed written informed consent.

6. Willingness and ability to comply with schedule for follow-up visits and postoperative
evaluations.

Exclusion Criteria:

1. Uncontrolled ocular inflammation (e.g., uveitis).

2. Preoperative intraocular pressure > 21 mm Hg.

3. Subjects with a current condition that, in the investigator's opinion, would interfere
with the treatment.

4. Subjects with any of the following conditions:

1. Severe chronic uveitis

2. Microphthalmus

3. Untreated retinal detachment

4. Untreated chronic glaucoma

5. Rubella cataract

6. Rubeosis of the iris

7. Proliferative diabetic retinopathy

5. Female subjects who are pregnant or lactating at the time of surgery.

6. Subjects with a known sensitivity to required postoperative study medications (4th
generation fluoroquinolone or steroid anti-inflammatory) if an alternative medication
is not available.

7. Subjects under legal guardianship or who, in the investigator's opinion, lack the
mental capacity to provide written informed consent for study participation.

8. Stargardt's retinopathy.

9. Subjects with gastric ulcers or diabetes mellitus in whom high doses of postoperative
steroids are required.

10. Surgical difficulty of the planned surgery, which might increase the potential for
complications.

11. No useful vision or vision potential in the fellow eye.

12. Clear crystalline lens.

13. Implantation of a CustomFlex Artificial Iris prosthesis in the contralateral eye
within the previous 4 weeks.

14. In the investigator's opinion, the presence of a condition or finding in the
contralateral eye that would make it unsafe to implant a CustomFlex Artificial Iris
prosthesis in the study eye.