QWU
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Prosthesis, Eyelid Spacer/Graft, Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3130
- Medical specialty
- Ophthalmic
- Flags
- Implant
- FDA definition
- For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid and eyelid area.
- Adverse events (MAUDE)
- 2024: 27
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 |
|---|---|---|
| CorNeat EverPatch (K223074) | Corneat Vision , Ltd. | 2023-06-02 |
Track QWU automatically
Every clearance here is in the API, with alerts when new ones post.