Bausch & Lomb Surgical, Inc.
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Bausch & Lomb Surgical, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-09-03FDA-DeviceClass IIIAkreos, 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.
- 2025-05-14FDA-DeviceClass IIntraocular 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.
- 2025-05-14FDA-DeviceClass IIntraocular 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.
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