Akreos, SKU: AO60P0300. Akreos intraocular lenses

FDA device recall Z-2451-2025 · posted 2025-08-26 · Open, Classified

Recall details

Recalling firm

Bausch & Lomb Surgical, Inc.

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

HQL

Quantity affected

2

Distribution

US: AZ, CA

Date initiated

2025-06-06

Date posted

2025-08-26

Location

Clearwater, FL