Intraocular Lens Recall: Bausch & Lomb Akreos AO60P0300
Announced 2025-09-03 · FDA
The FDA recall affects Akreos intraocular lenses from Bausch & Lomb Surgical, Inc. An off-power error produced a diopter of 16 instead of 3, which could lead to functional visual impairment or reduced visual acuity requiring optical or surgical correction. The recall involves 2 units distributed in the US (AZ, CA) with UDI-DI 10757770501783, Lot 1Q29212, and Serial Numbers 1Q29212006 and 1Q29212010.
| Brand | Bausch & Lomb Surgical, Inc. |
|---|---|
| Product | Akreos, SKU: AO60P0300. Akreos intraocular lenses |
| Reason | 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 reduction in visual acuity which could result in the need for optical or surgical correction. |
| Severity | low |
| Units affected | 2 |
| Distribution | US: AZ, CA |
| Agency | FDA |
| Recall / campaign no. | UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010 |
WHAT YOU SHOULD DO
- If you have this lens implanted, contact your ophthalmologist to determine if your device is affected by checking the listed lot/serial numbers: Lot 1Q29212; Serial 1Q29212006 or 1Q29212010.
- Schedule an evaluation with your eye care professional if you are experiencing vision changes or if your device is identified as affected.
- Do not attempt to remove or replace the lens yourself; follow your clinician's guidance and the recall instructions.
- For guidance and next steps, contact Bausch & Lomb or the FDA recall information channels.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.