Z-2451-2025 Class III Ongoing
FDA device recall Z-2451-2025 was initiated by Bausch & Lomb Surgical, Inc. on June 6, 2025 and is designated Class III. 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 redu… The recall status is ongoing. Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- September 3, 2025
- Initiation Date
- June 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
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.
Distribution Pattern
US: AZ, CA
Code Information
UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010