# P030002: Crystalens Model at-45 Accommodating Posterior Chamber Intraocular Lens (Iol)

- Pathway: PMA
- Applicant: Bausch & Lomb, Inc.
- Decided: Nov 14, 2003 after 294 days
- Product code: NAA (Lens, Intraocular, Accommodative)
- Device class: 3
- Regulation: 21 CFR 886.3600
- Recalls of this device: 1 (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
- Nov 14, 2011 · Not classified · Z-0445-2012: Bausch + Lomb voluntary initiated the recall due to a physician complaint of haze on the Crystalens AO which was visualized using an angled beam from a slit lamp during the post-operative examination.

Source page: https://510kreport.com/device/P030002
Methodology: https://510kreport.com/methodology