Akreos, SKU: AO60P0300. Akreos intraocular lenses
FDA Recall #Z-2451-2025 — Class III — June 6, 2025
Product Description
Akreos, SKU: AO60P0300. Akreos intraocular lenses
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.
Recalling Firm
Bausch & Lomb Surgical, Inc. — Clearwater, FL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
2
Distribution
US: AZ, CA
Code Information
UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated