Bausch And Lomb Surgical recalls
Bausch And Lomb Surgical appears in 10 official U.S. recall notices indexed by RecallRadar, most recently on 2025-09-03.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 10 |
|---|---|
| Published | 2014-02-26 to 2025-09-03 |
| By agency | FDA Device (10) |
| By classification | Class II (7), Class I (2), Class III (1) |
| By status | terminated (7), ongoing (3) |
| Distribution named in notices | AZ, CA, US |
Recalls
- Akreos, SKU: AO60P0300
FDA Device · Class III · 2025-09-03 · Bausch And Lomb Surgical
Reason: 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 acu… - Intraocular Lens. enVista Envy IOL, All models starting with EN
FDA Device · Class I · 2025-05-14 · Bausch And Lomb Surgical
Reason: 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. - Intraocular lens. enVista Monofocal IOL, All models starting with EE
FDA Device · Class I · 2025-05-14 · Bausch And Lomb Surgical
Reason: 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. - MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placeme…
FDA Device · Class II · 2020-12-09 · Bausch And Lomb Surgical
Reason: Product may be missing toric axis marks. - enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the…
FDA Device · Class II · 2020-07-22 · Bausch And Lomb Surgical
Reason: The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens. - enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adul…
FDA Device · Class II · 2018-12-26 · Bausch And Lomb Surgical
Reason: Cosmetic imperfections on the surface of some lenses. - 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…
FDA Device · Class II · 2017-05-24 · Bausch And Lomb Surgical
Reason: Complaints concerning kinked haptics that were occurring during lens delivery. - Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the capsu…
FDA Device · Class II · 2015-07-29 · Bausch And Lomb Surgical
Reason: Haptics breaking during lens loading and insertion. - Bausch & Lomb SofPort Advanced Optics Aspheric Lens
FDA Device · Class II · 2015-07-29 · Bausch And Lomb Surgical
Reason: Haptics breaking during lens loading and insertion. - Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual…
FDA Device · Class II · 2014-02-26 · Bausch And Lomb Surgical
Reason: Lens was manufactured with incorrect raw material.