The Recall Desk

Manufacturer

Bausch & Lomb Surgical, Inc.

10 recalls in our database name Bausch & Lomb Surgical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
10
Critical
0
Severe
2
Most recent
2025-09-03

Of the 10 recalls from Bausch & Lomb Surgical, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (20%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–10 of 10

  • SevereFDA (Devices)·Z-1680-2025·2025-05-14

    Intraocular Lenses enVista Envy and Envy Toric Recalled

    Bausch & Lomb is recalling enVista Envy and enVista Envy Toric intraocular lenses due to increased reports of toxic anterior segment syndrome (TASS) following implantation.

    Product
    Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1679-2025·2025-05-14

    Intraocular Lens Recalled Due to Toxic Anterior Segment Syndrome Reports

    Bausch & Lomb has recalled multiple enVista intraocular lens models used in cataract surgery due to reports of toxic anterior segment syndrome (TASS) in the United States. TASS is an inflammatory reaction in the front of the eye following lens implantation.

    Product
    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;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0519-2021·2020-12-09

    Bausch & Lomb Recalls Toric Intraocular Lenses Due to Missing Axis Marks

    Bausch & Lomb is recalling 31 MX60ET toric intraocular lenses because they may be missing toric axis marks, which are necessary for proper surgical placement.

    Product
    MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2552-2020·2020-07-22

    Bausch & Lomb Recalls enVista Toric Intraocular Lenses Due to Axis Misalignment

    Bausch & Lomb is recalling five enVista toric intraocular lenses because the toric axis marks were misaligned on an implanted lens.

    Product
    enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0628-2019·2018-12-26

    Bausch & Lomb Recalls enVista Intraocular Lenses Due to Surface Imperfections

    Bausch & Lomb is recalling 70,440 enVista intraocular lenses due to cosmetic surface imperfections. The lenses are distributed nationwide.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2098-2017·2017-05-24

    Bausch & Lomb Recalls SoftPort Easy-Load Lens Delivery System

    Bausch & Lomb is recalling specific lots of the SoftPort Easy-Load Lens Delivery System due to reports of kinked haptics during lens delivery.

    Product
    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 pull
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2154-2015·2015-07-29

    Bausch & Lomb SoFlex SE Intraocular Lens Recall for Haptic Breakage

    Bausch & Lomb is recalling SoFlex SE foldable intraocular lenses because haptics may break during loading and insertion.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1062-2014·2014-02-26

    Bausch & Lomb Recalls AKREOS AO Micro Incision Lenses Due to Material Error

    Bausch & Lomb is recalling 336 AKREOS AO Micro Incision Lenses because they were manufactured with incorrect raw material. The lenses are intended for cataract surgery.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide