Bausch & Lomb, Inc.
FDA adverse event reports naming Bausch & Lomb, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BAUSCH & LOMB, INC..
- Total reports
- 3,554
- Deaths
- 0
- Injuries
- 1,714
- Malfunctions
- 1,819
Reports per year
Source: FDA adverse event reports by year received, 2004–2020. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Intraocular LensHQL1,577
- Unit, PhacofragmentationHQC745
- Accessories, Soft Lens ProductsLPN506
- Folders And Injectors, Intraocular Lens (Iol)MSS138
- Instrument, Vitreous Aspiration And Cutting, Ac-PoweredHQE92
- Device, Irrigation, Ocular SurgeryKYG88
- Lenses, Soft Contact, Daily WearLPL73
- Lenses, Soft Contact, Extended WearLPM58
- Accessories, Solution, Ultrasonic Cleaners For LensesLYL57
- Lens, Intraocular, AccommodativeNAA41
Recent recalls
- 2017-01-10TerminatedError in labeling
Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient
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Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction. Therefore Bausch & Lomb is proposing a Field Correction to provide customer purchasing product from April 30, 2012 to June 20, 2016 with the current operating instruction.
- 2015-11-04TerminatedProcess control
BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number 8101403, and Biotrue ONEday 90 pack Carton International - Part Number 8098203.
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.
- 2014-12-23TerminatedSoftware Manufacturing/Software Deployment
Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
- 2014-12-23TerminatedSoftware Manufacturing/Software Deployment
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and certain treatments of the posterior portion of the eye.
A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
- 2014-12-23TerminatedSoftware Manufacturing/Software Deployment
Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhancement System with integrated laser module. System is used for the surgical treatment/removal of cataractous lens, vitreous removal and certain treatments of the posterior portion of the eye.
A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.
- 2014-10-24TerminatedOther
Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 fl. oz. (355 mL), Distributed by Walmart Stores, Inc.
Product lot did not meet the specification for its disinfectants at the time of manufacture.
- 2014-05-06TerminatedNonconforming Material/Component
Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.
Out of specification results for one of the two disinfectants.
- 2012-12-20TerminatedProcess control
Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectomy.
Posterior fluidics modules installed in the system may need to be recalibrated.
- 2011-08-30TerminatedNonconforming Material/Component
Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Ref: BL5110, packaged 6 units/case, RX, Sterile. Bausch & Lomb Incorporated, Rochester, NY For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery.
The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction
- 2011-08-30TerminatedNonconforming Material/Component
Bausch & Lomb Stellaris Basic Vacuum Phaco Pack, Ref: BL5111, packaged 6 units/case, RX, Sterile. Bausch & Lomb Incorporated, Rochester, NY For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery
The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction
Monitor Bausch & Lomb, Inc. automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.