Bausch & Lomb Surgical, Inc. recalls Akreos, SKU: AO60P0300. Akreos intraocular lenses
- Recall date
- June 6, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2451-2025
- FDA classification
- Class III
- Brand / firm
- Bausch & Lomb Surgical, Inc.
- Sold / distributed
- US: AZ, CA
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.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Akreos, SKU: AO60P0300. Akreos intraocular lenses
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