Class 3 Device Recall Akreos AO60 Intraocular Lens (IOL)

• Date Initiated by Firm: June 06, 2025
• Date Posted: August 26, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2451-2025
• Recall Event ID: 97232
• PMA Number: P060022
• Product Classification: intraocular lens - Product Code HQL
• Product: Akreos, SKU: AO60P0300. Akreos intraocular lenses
• Code Information: UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010
• Recalling Firm/ Manufacturer: Bausch & Lomb Surgical, Inc.; 21 N Park Place Blvd; Clearwater FL 33759-3917
• For Additional Information Contact: Caryn Marshall; 908-493-1381
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 2
• Distribution: US: AZ, CA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = HQL