Bausch & Lomb Surgical, Inc. recalls Akreos

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2451-2025
• FDA device classification · HQLOfficial FDA classification for this device type
• CFR regulation · 21 CFR 886.3600The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Bausch & Lomb Surgical, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.