NIZ · Class III — High Risk (PMA approval required, life-sustaining) · Ophthalmic · 21 CFR 886.3600
Classification
FDA Product Code
NIZ
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
21 CFR 886.3600
Review panel
OP
Medical specialty
Ophthalmic
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
Definition
An iris reconstruction lens is an intraocular lens (IOL) which is used in patients with partial or complete loss of the iris induced by trauma or congenital defect. The IOL serves as an artificial iris and lens, reducing light sensitivity and/or glare disability. The device is implanted in the capsular bag or sulcus for the correction of aphakia and aniridia.