Bausch & Lomb Surgical, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2451-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Akreos, SKU: AO60P0300. Akreos intraocular lenses

Product Classification:

Class III

Date Initiated: June 6, 2025

Date Posted: September 3, 2025

Recall Number: Z-2451-2025

Event ID: 97232

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.

Status: Ongoing

Product Quantity: 2

Code Information:

UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010

Distribution Pattern:

US: AZ, CA

Voluntary or Mandated:

Voluntary: Firm initiated