# Lens, Iris Reconstruction
> **Product code: NIZ** · Class III — High Risk (PMA approval required, life-sustaining) · Ophthalmic · 21 CFR 886.3600
## Classification
- **FDA Product Code:** NIZ
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** 21 CFR 886.3600
- **Review panel:** OP
- **Medical specialty:** Ophthalmic
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NIZ)
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