# P910061: Model LI30U Soflex (TM) UV-Absorb. Intraocular Lens

- Pathway: PMA
- Applicant: Bausch & Lomb
- Decided: Sep 2, 1994 after 1,060 days
- Product code: HQL (Intraocular Lens)
- Device class: 3
- Regulation: 21 CFR 886.3600
- Recalls of this device: 3 (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
- May 26, 2015 · Class II · Z-2154-2015: Haptics breaking during lens loading and insertion.
- May 26, 2015 · Class II · Z-2153-2015: Haptics breaking during lens loading and insertion.
- Nov 19, 2009 · Not classified · Z-0591-2010: Bausch & Lomb Incorporated, Rochester, NY is recalling their Silicone L161SE Intraocular Lens Lot 4916928 (23.5D) after receiving three customer complaints for what appears to be opacification of the 

Source page: https://510kreport.com/device/P910061
Methodology: https://510kreport.com/methodology