# HQL: Intraocular Lens

- Device class: 3; regulation: 21 CFR 886.3600; FDA's rule: PMA required
- FDA decisions: 65
- Recalls: 30 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 41
- 2018: 39
- 2019: 57
- 2020: 49
- 2021: 53
- 2022: 34
- 2023: 29
- 2024: 35
- 2025: 42
- 2026: 38

## Most-cited predicates
- K913626: Softrans Injector (1991), cited by 2
- K914311: Chiroflex II Lens Microsert (TM) (1992), cited by 1

Source page: https://510kreport.com/product-code/HQL
Data by year (CSV): https://510kreport.com/product-code/HQL.csv