Product code NIZ

Device name
Lens, Iris Reconstruction
Medical specialty
Ophthalmic
Device class
3
Regulation number
886.3600
Review panel
OP
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.
Source
FDA openFDA device classification dataset