NGY
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cannula, Trocar, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Medical specialty
- Ophthalmic
- FDA definition
- The trocar/cannula set is a manual surgical instrument intended for use as single-use, disposable cannula system for establishing an entry site conduit for passing ophthalmic instruments used to perform posterior ophthalmic surgical procedures.
- Adverse events (MAUDE)
- 2017: 46 · 2018: 25 · 2019: 15 · 2023: 32 · 2025: 21 · 2026: 68
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 |
|---|---|---|
| ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 (K012435) | Bausch & Lomb, Inc. | 2001-10-02 |
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