NIZClass IIIImplant
Lens, Iris Reconstruction
Ophthalmic · 21 CFR 886.3600
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.
MDR events2All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
2 adverse event reports on file
Event type breakdown
Injury2
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.