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Bausch & Lomb Surgical Recalls
10 recalls on record · February 26, 2014 to September 3, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 3, 2025Medical DevicesFDA
Bausch & Lomb Surgical, Inc. recalls Akreos, SKU: AO60P0300. Akreos intraocular lenses
Hazard: 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.
May 14, 2025Medical DevicesFDA
Bausch & Lomb Surgical, Inc. recalls Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
Hazard: 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.
May 14, 2025Medical DevicesFDA
Bausch & Lomb Surgical, Inc. recalls Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA;
Hazard: 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.
December 9, 2020Medical DevicesFDA
Bausch & Lomb Surgical, Inc. recalls MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is i
Hazard: Product may be missing toric axis marks.
July 22, 2020Medical DevicesFDA
Bausch & Lomb Surgical, Inc. recalls enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary
Hazard: The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
December 26, 2018Medical DevicesFDA
Bausch & Lomb Surgical, Inc. recalls enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correc
Hazard: Cosmetic imperfections on the surface of some lenses.
May 24, 2017Medical DevicesFDA
Bausch & Lomb Surgical, Inc. recalls SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, o
Hazard: Complaints concerning kinked haptics that were occurring during lens delivery.
July 29, 2015Medical DevicesFDA
Bausch & Lomb Surgical, Inc. recalls Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary im
Hazard: Haptics breaking during lens loading and insertion.
July 29, 2015Medical DevicesFDA
Bausch & Lomb Surgical, Inc. recalls Bausch & Lomb SofPort Advanced Optics Aspheric Lens
Hazard: Haptics breaking during lens loading and insertion.
February 26, 2014Medical DevicesFDA
Bausch & Lomb Surgical, Inc. recalls Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of
Hazard: Lens was manufactured with incorrect raw material.