Z-2451-2025Class III

Akreos, SKU: AO60P0300. Akreos intraocular lenses

Name: Z-2451-2025 Akreos, SKU: AO60P0300. Akreos intraocular lenses
Creator: Bausch & Lomb Surgical, Inc.
Published: 2025-06-06
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2025-06-06 / Open, Classified / root cause: manufacturing process

FDA source

Bausch & Lomb Surgical, Inc. began a recall of Akreos, SKU: AO60P0300. Akreos intraocular lenses on 2025-06-06. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2451-2025
Classification: Class III
Status: Open, Classified
Initiated: 2025-06-06
Posted: 2025-08-26
Recalling firm: Bausch & Lomb Incorporated
Product: Akreos, SKU: AO60P0300. Akreos intraocular lenses
Product code: HQL Intraocular Lens
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.
Root cause tag: manufacturing process
FDA 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 [email protected] For questions regarding this notice, please call firm at 1-800-338-2020, Option 9.
Quantity in commerce: 2
Distribution: US: AZ, CA
Product codes and lots: UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2451-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2451-2025	Class III	Ongoing	Voluntary: Firm initiated	2025-09-03	2025-08-26

Product code HQL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)