Akreos Intraocular Lens (Bausch & Lomb) – Diopter Calculation Error (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Brand
Bausch & Lomb Surgical, Inc.
Lot Codes / Batch Numbers
UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010
Products Sold
UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010
Bausch & Lomb Surgical, Inc. is recalling Akreos, SKU: AO60P0300. Akreos intraocular lenses due to An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens co. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
6/6/2025, recall notices were emailed to customers who were asked to do the following: 1) Check your inventory, quarantine, and do not use the IOL from this impacted lot. 2) Provide this notice to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred (as appropriate). Also, please transfer this notice to other organizations on which this action has an impact (as appropriate). Please maintain awareness of this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. 3) Complete and return the acknowledgement form via email to BLSurgCustSvc@Bausch.com For questions regarding this notice, please call firm at 1-800-338-2020, Option 9.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA
Page updated: Jan 10, 2026