FDA product code NIZ: Lens, Iris Reconstruction
NIZ is the FDA product code for lens, iris reconstruction. It is a Class III device, regulated under 21 CFR 886.3600 and reviewed by the Ophthalmic panel. Devices under NIZ reach the market by PMA; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Lens, Iris Reconstruction |
| Device class | Class III |
| Regulation | 21 CFR 886.3600 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | PMA |
| Implant | Yes |
Recalls for NIZ devices
openFDA lists no recalls for product code NIZ.
Frequently asked questions
What is FDA product code NIZ?
NIZ is the FDA product code for lens, iris reconstruction. It is a Class III device, regulated under 21 CFR 886.3600 and reviewed by the Ophthalmic panel.
What device class is NIZ?
Class III, regulation 21 CFR 886.3600. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NIZ
- Run a recall and safety report across every NIZ manufacturer
- Watch product code NIZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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