Clearwater, FL, United States
Bausch & Lomb Surgical, Inc. recalls
5 recalls recorded since 2018, most recently on 6 June 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)2
Terminated or completed3
Class I (FDA)1
Ongoing Class III Medical devices
- Recall started
- 6 June 2025
- 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 acuity which could result in the need for optical or surgical correction.
- Distribution
- US: AZ, CA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2451-2025
- Akreos, SKU: AO60P0300. Akreos intraocular lenses
Ongoing Class I Medical devices
- Recall started
- 27 March 2025
- 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.
- Distribution
- Worldwide distribution. US Nationwide including PR and GU, and the countries of CAN, AUS, AUT, BEL, BGR, IC, HRV, CZE, FRA, DEU, GRC, HUN, ITA, NLD, POL, PRT, ROU, ESP, GBR, NZL, HKG.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1680-2025, Z-1679-2025
- Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
- 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 st
Terminated Class II Medical devices
- Recall started
- 7 November 2020
- Terminated
- 11 July 2024
- Reason
- Product may be missing toric axis marks.
- Distribution
- US Nationwide distribution including in the states of FL, CA, MO, MN, TN, TX, MI, WA, UT, NH, and OH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0519-2021
- MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag.
Terminated Class II Medical devices
- Recall started
- 9 June 2020
- Terminated
- 11 February 2021
- Reason
- The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens.
- Distribution
- U.S. Nationwide distribution including in the states of IN, SC, CT, NV, and NC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2552-2020
- 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 c
Terminated Class II Medical devices
- Recall started
- 5 November 2018
- Terminated
- 4 November 2019
- Reason
- Cosmetic imperfections on the surface of some lenses.
- Distribution
- US Nationwide Distribution: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL IN, KS, KY, la, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0628-2019
- 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 intende
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.