NIZ: Lens, Iris Reconstruction
FDA product code NIZ. Class III, classified under 21 CFR 886.3600. What the classification flags say about Part 820 under the QMSR.
As of Nov 2, 2026, FDA product code NIZ (Lens, Iris Reconstruction) is Class III under 21 CFR 886.3600, reviewed through PMA, with 0 linked 510(k), De Novo or BK numbers, 0 PMAs and 0 recall product records.
Classification
- Product code
- NIZ
- Device name
- Lens, Iris Reconstruction
- Device class
- Class III
- Regulation
- 21 CFR 886.3600
- Review panel
- Ophthalmic
- Premarket route
- PMA
- CGMP-exempt flag
- No
- Life-sustaining flag
- No
- Implant flag
- Yes
- Third-party review
- Not a candidate
- Summary malfunction reporting
- Eligible
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.
Data from openFDA as of 2 November 2026. Read the record on openFDA · FDA product code classification database
Part 820 requirements the flags point to
Part 820 rules for NIZ
- CGMP exemptionClassification regulation, 21 CFR parts 862 to 892
- Not flaggedFDA does not flag this product code as exempt.A manufacturer of a finished device of this type falls under part 820 (21 CFR 820.1(a)). Some classification regulations exempt only part of a generic device type, so read the regulation for your device.FDA: QMSR, CGMP exemptions · 21 CFR 820.35
- Design and development, ISO 13485 clause 7.321 CFR 820.10(c)
- Rule names this classRule names Class III.21 CFR 820.10(c) requires manufacturers of class II and class III devices to comply with clause 7.3 and its subclauses.21 CFR 820.10
- Traceability, ISO 13485 clause 7.5.9.221 CFR 820.10(d)
- Not flaggedFDA does not flag this code as life-supporting or life-sustaining.The code is flagged as an implant. 820.10(d) names devices that support or sustain life. The old rule, 820.65, also named devices intended for surgical implant. FDA said the scope of 820.10(d) is substantially similar to the old rule. The flag shows implant status. It does not decide whether 820.10(d) applies.21 CFR 820.10 · 21 CFR 860.3 · QMSR final rule, comment 49
- Complaint and record content21 CFR 820.35
- Rule names this classApplies to every finished-device manufacturer, exempt or not.820.35 adds content to complaint records, servicing records and UDI recording on top of ISO 13485 clause 4.2.5. FDA says CGMP exemption does not lift these records.21 CFR 820.35 · FDA: QMSR, CGMP exemptions
These flags describe the classification of a product code. They are not a determination for a specific device or manufacturer. How a manufacturer meets 21 CFR 820.10 depends on its own device, its intended use and the full text of the rule.
Clearances and recalls on record
- 510(k), De Novo and BK numbers linked
- 0
- PMA numbers linked
- 0
- Recall product records
- 0
- Adverse event reports
- Search MAUDE for NIZ
Recall records count products, and one recall event can add many. Counts show activity in a category. They do not measure its safety.
Search all 7,098 product codes, or read the guide to the Part 820 rules behind these flags.
Check your quality documents against Part 820
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