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Bausch & Lomb Surgical, Inc. recalls Akreos, SKU: AO60P0300. Akreos intraocular lenses
Recalled September 3, 2025 · FDA recall Z-2451-2025 · Bausch & Lomb Surgical
Hazard
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 Class III
Units
2
Sold at
US: AZ, CA
Description
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.
Product
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Manufacturer(s)
Bausch & Lomb Surgical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →