Bausch & Lomb Surgical, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 10 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 7
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2451-2025 | Class III | Akreos, SKU: AO60P0300. Akreos intraocular lenses | June 6, 2025 |
| Z-1679-2025 | Class I | Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All model | March 27, 2025 |
| Z-1680-2025 | Class I | Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models | March 27, 2025 |
| Z-0519-2021 | Class II | MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product | November 7, 2020 |
| Z-2552-2020 | Class II | enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is in | June 9, 2020 |
| Z-0628-2019 | Class II | enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation f | November 5, 2018 |
| Z-2098-2017 | Class II | SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of th | April 5, 2017 |
| Z-2154-2015 | Class II | Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are int | May 26, 2015 |
| Z-2153-2015 | Class II | Bausch & Lomb SofPort Advanced Optics Aspheric Lens | May 26, 2015 |
| Z-1062-2014 | Class II | Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in | October 16, 2013 |