LWL
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Fluid, Intraocular
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 886.4275
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 2012: 6 · 2016: 13 · 2022: 13 · 2023: 18 · 2025: 27 · 2026: 18
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 |
|---|---|---|
| OMS SILICONE OIL INJECTOR (K844895) | Optical Micro Systems, Inc. | 1985-06-24 |
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Every clearance here is in the API, with alerts when new ones post.