NIZ
- Product code
- NIZ
- Device name
- Lens, Iris Reconstruction
- Device class
- Class 3
- 21 CFR
- 21 CFR 886.3600
- Medical specialty
- Ophthalmic
- Marketing pathway
- PMA
- Flag
- Implant
FDA classification 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.
Official FDA classification page: NIZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).