Bausch & Lomb Surgical

Reports per year

Source: FDA adverse event reports by year received, 1998–2015. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Top device categories

• Intraocular LensHQL683
• Instrument, Vitreous Aspiration And Cutting, Ac-PoweredHQE162
• Unit, PhacofragmentationHQC136
• Device, Irrigation, Ocular SurgeryKYG72
• Folders And Injectors, Intraocular Lens (Iol)MSS44
• Keratome, Ac-PoweredHNO40
• System, Imaging, Pulsed Echo, UltrasonicIYO17
• Aid, Surgical, ViscoelasticLZP16
• Lens, Intraocular, AccommodativeNAA11
• Cannula, OphthalmicHMX9

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.

• 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.

• 2014-02-20TerminatedNonconforming Material/Component

  Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL 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.

  Lens was manufactured with incorrect raw material.

• 2004-07-20TerminatedOther

  SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens.

  Lens may be labeled with incorrect diopter size.

• TerminatedProcess change control

  MX60ET (enhanced enVista Toric) enVista One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.

  Product may be missing toric axis marks.

• TerminatedProcess control

  enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed. The lens is intended for placement in the capsular bag.

  Cosmetic imperfections on the surface of some lenses.

• TerminatedDevice Design

  SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into the eye. The SofPort Easy-Load Lens Delivery System consists of a syringe shaped body and tip with a plunger, drawer, and haptic puller. It is a sterile, disposable plastic device designed for single use only.

  Complaints concerning kinked haptics that were occurring during lens delivery.