# P910056: Soflex UV-Absorbing Silicone Posterior Chamber Intraocular Lens

- Pathway: PMA
- Applicant: Bausch & Lomb, Inc.
- Decided: Jan 17, 1992 after 121 days
- Product code: HQL (Intraocular Lens)
- Device class: 3
- Regulation: 21 CFR 886.3600
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jun 9, 2020 · Class II · Z-2552-2020: The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
- Nov 5, 2018 · Class II · Z-0628-2019: Cosmetic imperfections on the surface of some lenses.

Source page: https://510kreport.com/device/P910056
Methodology: https://510kreport.com/methodology