Bausch & Lomb Surgical recalls

2 official recalls and safety alerts involving Bausch & Lomb Surgical since 2025-05, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Bausch & Lomb Surgical or the relevant agency.

  1. 2025-09-03
  2. US
    Drugs & medicalClass III

    Bausch & Lomb Surgical, Inc. recalls Akreos, SKU: AO60P0300. Akreos intraocular lenses

    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…

    FDA · DeviceBausch & Lomb Surgical, Inc.US: AZ, CAOfficial notice →
  3. 2025-05-14
  4. US
    Drugs & medicalClass I

    Bausch & Lomb Surgical, Inc. recalls Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.

    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.

    FDA · DeviceBausch & Lomb Surgical, Inc.Worldwide distribution. US Nationwide including PR and GU, and the countries…Official notice →