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

Inclusion Criteria: For the IDE study, subjects in whom the subject and study eye meet all of the followingcriteria were candidates for the PMA cohort of this study, or the Continued Access cohortafter the PMA cohort was enrolled:

1. 22 years of age or older
2. Having a diagnosis of congenital or acquired full or partial iris defect in the studyeye.
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 postoperativeevaluations. All adult and pediatric subjects who participated in the 12-month AI-001 IDE clinical trialwho meet the following inclusion criteria are eligible for enrollment in the PAS; hereafterreferred to as the "Long Term Extension Cohort":
7. Previous AI-001 IDE study participant who was enrolled before PMA approval (i.e.,before May 30, 2018) and has had the CustomFlex™ Artificial Iris implanted for 36months or less if enrolled as an adult or for 60 months or less if enrolled as apediatric subject.
8. Signed and received a copy of the signed written informed consent.
9. Willingness and ability to comply with schedule for follow-up visits and postoperativeevaluations. Pediatric subjects in whom the subject and study eye meet all of the following criteria arecandidates for enrollment in the Pediatric New Enrollment Cohort:
10. Age between 3 years and less than 22 years at the time of consent for the OSB PAS.
11. Having a diagnosis of congenital or acquired full or partial iris defect in the studyeye.
12. Having symptoms of light sensitivity, photophobia, and/or glare or other aniridicsymptoms in the study eye.
13. Subjects should be pseudophakic, aphakic or require cataract extraction.
14. Signed and received a copy of the signed written informed consent for the OSB PAS.
15. Willingness and ability to comply with schedule for follow-up visits and postoperativeevaluations.

Exclusion Criteria: There are no exclusion criteria for the Long Term Extension Cohort . For the IDE study, all subjects in whom the subject or study eye meets any of the followingcriteria will were excluded from the PMA cohort of this study, or the Continued Accesscohort after the PMA cohort was enrolled:

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 interferewith the treatment.
4. Subjects with any of the following conditions:
5. Severe chronic uveitis
6. Microphthalmus
7. Untreated retinal detachment
8. Untreated chronic glaucoma
9. Rubella cataract
10. Rubeosis of the iris
11. Proliferative diabetic retinopathy
12. Female subjects who are pregnant or lactating at the time of surgery.
13. Subjects with a known sensitivity to required postoperative study medications (4thgeneration fluoroquinolone or steroid anti-inflammatory) if an alternative medicationis not available.
14. Subjects under legal guardianship or who, in the investigator's opinion, lack themental capacity to provide written informed consent for study participation.
15. Stargardt's retinopathy.
16. Subjects with gastric ulcers or diabetes mellitus in whom high doses of postoperativesystemic steroids are required.
17. Surgical difficulty of the planned surgery, which might increase the potential forcomplications.
18. No useful vision or vision potential in the fellow eye.
19. Clear crystalline lens (in eyes with intact natural, crystalline lens).
20. Implantation of a CustomFlex™ Artificial Iris prosthesis in the contralateral eyewithin the previous 4 weeks.
21. In the investigator's opinion, the presence of a condition or finding in thecontralateral eye that would make it unsafe to implant a CustomFlex™ Artificial Irisprosthesis in the study eye. All pediatric subjects in whom the subject or study eye meets any of the following criteriawill be excluded from enrollment in the Pediatric New Enrollment Cohort:
22. Uncontrolled ocular inflammation (e.g., uveitis).
23. Preoperative intraocular pressure > 21 mm Hg.
24. Subjects with a current condition that, in the investigator's opinion, would interferewith the treatment.
25. Subjects with any of the following conditions:
26. Severe chronic uveitis
27. Microphthalmus
28. Untreated retinal detachment
29. Untreated chronic glaucoma
30. Rubella cataract
31. Rubeosis of the iris
32. Proliferative diabetic retinopathy
33. Intraocular infections
34. Severe endothelial corneal dystrophy.
35. Subjects in whom an ocular surgery to treat an existing condition is planned to beperformed in the study eye within 6 months after the artificial iris implant surgeryday.
36. Female subjects who are pregnant or lactating at the time of surgery.
37. Subjects with a known sensitivity to required postoperative study medications (4thgeneration fluoroquinolone or steroid anti-inflammatory) if an alternative medicationis not available.
38. Subjects under legal guardianship or who, in the investigator's opinion, lack themental capacity to provide written informed consent for study participation.
39. Stargardt's retinopathy.
40. Subjects with gastric ulcers or diabetes mellitus in whom high doses of postoperativesystemic steroids are required.
41. Surgical difficulty of the planned surgery, which might increase the potential forcomplications.
42. No useful vision or vision potential in the fellow eye.
43. Clear crystalline lens (in eyes with intact natural, crystalline lens).
44. Implantation of a CustomFlex™ Artificial Iris prosthesis in the contralateral eyewithin the previous 4 weeks.
45. In the investigator's opinion, the presence of a condition or finding in thecontralateral eye that would make it unsafe to implant a CustomFlex™ Artificial Irisprosthesis in the study eye.