Reported Sep 3, 2025 · Ongoing
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Bausch & Lomb Surgical, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bausch & Lomb Surgical, Inc. · 21 N Park Place Blvd · Clearwater, FL · 33759-3917
Is this the product you have?
- Akreos
- SKUAO60P0300. Akreos intraocular lenses
- Lot codes and dates
- UDI-DI10757770501783
- Lot1Q29212
- Serial Numbers1Q29212006 and 1Q29212010
- Amount recalled
- 2
Where it was sold
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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