Recall Z-2451-2025— Bausch & Lomb Surgical, Inc.
Class III · Ongoing
Class III FDA medical device recall by Bausch & Lomb Surgical, Inc., initiated 2025-06-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Akreos, SKU: AO60P0300. Akreos intraocular lenses. Reason: 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.
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2025-06-06
- Firm location
- Clearwater, FL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.