RegWardenFDA facility compliance records
Company

Bausch & Lomb Incorporated

8 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2012: 1 recalls; 2014: 1 recalls; 2015: 1 recalls; 2016: 3 recalls; 2017: 1 recalls; 2018: 1 recalls1’12’131’141’153’161’171’18’19’20’21’22’23’24’25’26
  • Recalls (8)

Registered facilities (10)

Recalls & enforcement

  • Class IITerminated2018-08-08
    The back cap separates from the body of the vitrectomy cutter.
  • Class IITerminated2017-03-03
    The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration…
  • Class IITerminated2016-10-12
    According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of SKU 0816 C (Pterygium Burr Medium Diamond). Further investigation found that repackaged Algerbrush-I…
  • Class IITerminated2016-09-19
    Product was found to contain excess residual levels of hydrogen peroxide.
  • Class IITerminated2016-07-11
    Possible dull knife edge
  • Class IITerminated2015-09-03
    The firm determined that 25 lots had been manufactured with a minor surface defect occurring in the optical surface on each lens. Complaints of Halo or Poor Visual Acuity.
  • Class IITerminated2014-11-04
    A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
  • Class IITerminated2012-08-31
    Posterior fluidics modules installed in the system may need to be recalibrated.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Bausch & Lomb Incorporated — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9913003-bausch-lomb-incorporated/

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