Intraocular Lens Recall: Bausch & Lomb Akreos AO60P0300
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 |
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.
How to identify the recalled item
| Lot / date codes | UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010 |
|---|---|
| Lot / date codes | UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other intraocular lens recalls
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.