# QCB: Phakic Toric Intraocular Lens

- Device class: 3; regulation: 21 CFR 886.3600; FDA's rule: PMA required
- FDA decisions: 0
- Recalls: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2018: 1
- 2025: 1

## Most-cited predicates

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