Class III
Medical Device Recall: Akreos, SKU: AO60P0300. Akreos intraocular lenses
Bausch & Lomb Surgical, Inc. · June 6, 2025
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.
Distribution
US: AZ, CA
States Affected
AZ, CA
Quantity Affected
2
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2451-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.