FDAHealthJune 6, 2025
Bausch & Lomb Surgical, Inc. — Akreos, SKU: AO60P0300. Akreos intraocular lenses
⚠️ 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.
Is this relevant to me?
- Geography
- US, AZ, CA
- Source agency
- FDA
- Category
- Health
- Published
- June 6, 2025
US: AZ, CA
What's affected?
- Product
- Akreos, SKU: AO60P0300. Akreos intraocular lenses
- Lot code
- 1Q29212
Additional details
UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 2.
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