Akreos IOL recallZ-2451-2025 · Bausch & Lomb Surgical, Inc. · initiated Jun 6, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bausch & Lomb Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2451-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 6, 2025
- Posted by the FDA
- Aug 26, 2025
- Recalling firm
- Bausch & Lomb Surgical, Inc.
- Quantity
- 2
- Product code
- HQL
- FDA submissions
- P060022
- Distribution
- US: AZ, CA
Product description
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Code information (models, lots, serial numbers)
UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Akreos® IOL AO60Bausch & Lomb Incorporated · Intraocular Lens1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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