FDA Medical Device Recalls (openFDA)
Bausch & Lomb Surgical, Inc.: Akreos, SKU: AO60P0300. Akreos intraocular lenses
- Recall number
- Z-2451-2025
- Recalling firm
- Bausch & Lomb Surgical, Inc.
- Product
- Akreos, SKU: AO60P0300. Akreos intraocular lenses
- Status
- Open, Classified
- Initiated
- 2025-06-06
- Posted
- 2025-08-26
- Terminated
- not on file
- 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.
- Root 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
- 2
- Distribution
- US: AZ, CA
- Lot, serial or model codes
- UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010
- 510(k) numbers
- not on file
- PMA numbers
- ["P060022"]
- Product code
- HQL
- Firm FEI
- 1119279
- Firm city
- Clearwater
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28