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Bausch & Lomb Surgical, Inc.

Country not established

Devices
1
FDA recalls
113 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue1

Newest first, rows 1-1 of 1

FDA recalls11

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 1
  • 2018 1
  • 2019 0
  • 2020 2
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 3
  • 2026 0

4 initiated before 2017

Showing the 10 most recent of 11 recalls.

  • 2025

    • 6 Jun 2025 Z-2451-2025 Class III Ongoing 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: US: AZ, CA Submission number: P060022
    • 27 Mar 2025 Z-1679-2025 Class I Ongoing 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. Distribution: Worldwide distribution. US Nationwide including PR and GU, and the countries of CAN, AUS, AUT, BEL, BGR, IC, HRV, CZE,…
      Full distribution text Worldwide distribution. US Nationwide including PR and GU, and the countries of CAN, AUS, AUT, BEL, BGR, IC, HRV, CZE, FRA, DEU, GRC, HUN, ITA, NLD, POL, PRT, ROU, ESP, GBR, NZL, HKG.
      Submission number: P910056S051
    • 27 Mar 2025 Z-1680-2025 Class I Ongoing 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. Distribution: Worldwide distribution. US Nationwide including PR and GU, and the countries of CAN, AUS, AUT, BEL, BGR, IC, HRV, CZE,…
      Full distribution text Worldwide distribution. US Nationwide including PR and GU, and the countries of CAN, AUS, AUT, BEL, BGR, IC, HRV, CZE, FRA, DEU, GRC, HUN, ITA, NLD, POL, PRT, ROU, ESP, GBR, NZL, HKG.
      Submission number: P240005

  • 2020

    • 7 Nov 2020 Z-0519-2021 Class II Terminated Product may be missing toric axis marks. Distribution: US Nationwide distribution including in the states of FL, CA, MO, MN, TN, TX, MI, WA, UT, NH, and OH. Submission number: P910056S036
    • 9 Jun 2020 Z-2552-2020 Class II Terminated The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens. Distribution: U.S. Nationwide distribution including in the states of IN, SC, CT, NV, and NC. Submission number: P910056

  • 2018

    • 5 Nov 2018 Z-0628-2019 Class II Terminated Cosmetic imperfections on the surface of some lenses. Distribution: US Nationwide Distribution: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL IN, KS, KY, la, MA, MD, ME, MI, MN, MO, MS,…
      Full distribution text US Nationwide Distribution: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL IN, KS, KY, la, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
      Submission number: P910056

  • 2017

    • 5 Apr 2017 Z-2098-2017 Class II Terminated Complaints concerning kinked haptics that were occurring during lens delivery. Distribution: Nationwide Distribution to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO,…
      Full distribution text Nationwide Distribution to AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico
      Submission number: K970727

  • 2015

    • 26 May 2015 Z-2153-2015 Class II Terminated Haptics breaking during lens loading and insertion. Distribution: Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA,…
      Full distribution text Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MD, MN, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, Hawaii and Puerto Rico and countries of: Canada, Brazil, Argentina, Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Georgia, Greece, Kyrgyzstan, Norway, Russia, Ukraine, United Arab Emirates, China, Australia, India Malaysia, Korea, and Taiwan.
      Submission number: P910061
    • 26 May 2015 Z-2154-2015 Class II Terminated Haptics breaking during lens loading and insertion. Distribution: Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA,…
      Full distribution text Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MD, MN, MO, MS, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, Hawaii and Puerto Rico and countries of: Canada, Brazil, Argentina, Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Georgia, Greece, Kyrgyzstan, Norway, Russia, Ukraine, United Arab Emirates, China, Australia, India Malaysia, Korea, and Taiwan.
      Submission number: P910061

  • 2013

    • 16 Oct 2013 Z-1062-2014 Class II Terminated Lens was manufactured with incorrect raw material. Distribution: Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia…
      Full distribution text Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe.
      Submission number: P060022
Show all 11 recalls

  • 2004

    • 27 Feb 2004 Z-1093-04 Unclassified (pre-2012) Terminated Lens may be labeled with incorrect diopter size. Distribution: Nationwide & puerto rico. FL, MA, CA, CT, MI, NY, IN, ID, GA, PA, IL, CO, TN, NC, PR, TX, ME and OH.

Frequently asked questions

How many devices does Bausch & Lomb Surgical, Inc. have in the registry?

The registry currently lists 1 device for Bausch & Lomb Surgical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bausch & Lomb Surgical, Inc.'s devices?

Among its 1 most recently registered device, Bausch & Lomb Surgical, Inc. has devices listed in FDA PMA (1 device).

What risk classes do Bausch & Lomb Surgical, Inc.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Bausch & Lomb Surgical, Inc.'s devices are Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for Bausch & Lomb Surgical, Inc.?

FDA recall records list 11 recalls initiated by Bausch & Lomb Surgical, Inc., the most recent initiated on 6 Jun 2025. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Bausch & Lomb Surgical, Inc. in the registry?

The most recently registered devices listed for Bausch & Lomb Surgical, Inc. include KELMAN(TM) OMNIFIT II MODEL 2100.

Generated automatically from registry data and not verified by a human reviewer.