Akreos recall
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Why was Akreos 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010
- Product
- Akreos, SKU: AO60P0300. Akreos intraocular lenses
- Recalling firm
- Bausch & Lomb Surgical, Inc.
- Quantity
- 2
- Distribution
- US: AZ, CA
- Recall date
- September 3, 2025
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)