Bausch & Lomb
FDA adverse event reports naming Bausch & Lomb as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BAUSCH & LOMB.
- Total reports
- 8,706
- Deaths
- 0
- Injuries
- 4,421
- Malfunctions
- 4,163
Reports per year
Source: FDA adverse event reports by year received, 2009–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Intraocular LensHQL5,774
- Folders And Injectors, Intraocular Lens (Iol)MSS671
- Unit, PhacofragmentationHQC652
- Accessories, Soft Lens ProductsLPN549
- Keratome, Ac-PoweredHNO195
- Lens, Intraocular, AccommodativeNAA182
- Lens, Guide, IntraocularKYB172
- Instrument, Vitreous Aspiration And Cutting, Ac-PoweredHQE118
- Device, Irrigation, Ocular SurgeryKYG65
- Lenses, Soft Contact, Extended WearLPM54
Recent recalls
- 2025-08-26Open, ClassifiedProcess control
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 acuity which could result in the need for optical or surgical correction.
- 2025-05-02Open, ClassifiedProcess control
Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;
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.
- 2025-05-02Open, ClassifiedProcess control
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.
- 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.
- 2015-07-20TerminatedDevice Design
Bausch & Lomb SofPort Advanced Optics Aspheric Lens
Haptics breaking during lens loading and insertion.
- 2015-07-20TerminatedDevice Design
Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
Haptics breaking during lens loading and insertion.
- 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.
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