HQL
5 FDA 510(k) clearances · Product code
104 daysmedian time to decision
125 days90th percentile
5clearances measured
FDA profile
- Official device name
- Intraocular Lens
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 886.3600
- Medical specialty
- Ophthalmic
- Flags
- Implant
- Adverse events (MAUDE)
- 2021: 2,925 · 2022: 3,290 · 2023: 3,906 · 2024: 4,162 · 2025: 5,388 · 2026: 3,116
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 |
|---|---|---|
| CHIROFLEX II LENS MICROSERT(TM) (K914311) | Chiron Ophthalmics | 1992-01-27 |
| SOFTRANS INJECTOR (K913626) | Staar Surgical Co. | 1991-12-18 |
| NIDEK DIGITAL KERATOMETER (K842892) | Nidek, Inc. | 1984-10-05 |
| AMER. MEDICAL OPTICS DIGITAL KERATO- (K842504) | American Medical Optics | 1984-10-01 |
| CILCO ANTERIOR CHAMBER LENS (K771933) | California Intraocular Lens | 1978-01-26 |
Track HQL automatically
Every clearance here is in the API, with alerts when new ones post.