# P060022: Akreos Posterior Chamber Intraocular Lens,Model Adapt

- Pathway: PMA
- Applicant: Bausch & Lomb, Inc.
- Decided: Sep 5, 2008 after 799 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
- Jun 6, 2025 · Class III · Z-2451-2025: An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or redu
- Oct 16, 2013 · Class II · Z-1062-2014: Lens was manufactured with incorrect raw material.
- Dec 8, 2008 · Not classified · Z-1911-2009: Affected lenses were inadvertently shipped to Bausch & Lomb's European Logistics Center (ELC) prior to release authorization. Initial testing indicated the product did not meet release criteria for en

Source page: https://510kreport.com/device/P060022
Methodology: https://510kreport.com/methodology