Bausch & Lomb Surgical, Inc.: Device Recall

Recall Details

Recall Number

Z-2451-2025

Classification

Class III

Product Type

Device

Recalling Firm

Bausch & Lomb Surgical, Inc.

Status

Ongoing

Date Initiated

06/06/2025

Location

Clearwater, FL, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

2

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.

Product Description

Akreos, SKU: AO60P0300. Akreos intraocular lenses

Distribution Pattern

US: AZ, CA

Other Recalls by Bausch & Lomb Surgical, Inc.

• Class I: Dangerous 03/27/2025
  In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
• Class I: Dangerous 03/27/2025
  In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.

View all recalls by Bausch & Lomb Surgical, Inc. →