NIZ — Lens, Iris Reconstruction Class III
FDA product code NIZ covers "Lens, Iris Reconstruction", a Class III medical device regulated under 21 CFR 886.3600. Submissions are reviewed by the Ophthalmic panel. Devices under this code are implants.
Classification Details
- Product Code
- NIZ
- Device Class
- Class III
- Regulation Number
- 886.3600
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- Yes
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.