510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NIZClass III

Lens, Iris Reconstruction

21 CFR 886.3600 / Ophthalmic
FDA source (opens on fda.gov)

NIZ is the FDA product code for Lens, Iris Reconstruction, a class III device type, regulated under 21 CFR 886.3600. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NIZ
Device name
Lens, Iris Reconstruction
FDA 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.
Regulation
21 CFR 886.3600
Device class
Class III
Review panel
Ophthalmic
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NIZ.