NQB
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Conformer, Ophthalmic, Biological Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3130
- Medical specialty
- Ophthalmic
- Flags
- Implant
- FDA definition
- The ophthalmic conformer with molded plastic and biological tissue insert is introduced temporarily between the eyeball and eyelid to maintain space in the orbital cavity, prevent closure or adhesions during the healing process following surgery, and enables positioning of biological tissue to the ocular surface without the need for sutures.
- Adverse events (MAUDE)
- 2026: 32
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AMNIOLENS (K032104) | Bio-Tissue, Inc. | 2003-12-12 |
Track NQB automatically
Every clearance here is in the API, with alerts when new ones post.