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Bausch & Lomb Surgical, Inc.

7 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Akreos, SKU: AO60P0300. Akreos intraocular lenses recall (Z-2451-2025)Bausch & Lomb Surgical, Inc.2025-08-26
Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, recall (Z-1679-2025)Bausch & Lomb Surgical, Inc.2025-05-02
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, A recall (Z-1680-2025)Bausch & Lomb Surgical, Inc.2025-05-02
Bausch & Lomb SofPort Advanced Optics Aspheric Lens recall (Z-2153-2015)Bausch & Lomb Surgical, Inc.2015-07-20
Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs a recall (Z-2154-2015)Bausch & Lomb Surgical, Inc.2015-07-20
Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantati recall (Z-1062-2014)Bausch & Lomb Surgical, Inc.2014-02-20
SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens. recall (Z-1093-04)Bausch & Lomb Surgical, Inc.2004-07-20

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Every clearance here is in the API, with alerts when new ones post.