Company
Bausch & Lomb Surgical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2025 | Bausch & Lomb Surgical, Inc. Akreos, SKU: AO60P0300. Akreos intraocular lenses Open, Classified |
HQL | None listed |
| May 2, 2025 | Bausch & Lomb Surgical, Inc. Intraocular Lens. enVista Envy IOL, All models starting with EN;
enVista Envy Toric IOL, All models starting with ETN. Open, Classified |
MFK | None listed |
| May 2, 2025 | Bausch & Lomb Surgical, Inc. 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 I Open, Classified |
HQL | None listed |
| Nov 7, 2020 | Bausch & Lomb Surgical, Inc. 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 |
MJP | None listed |
| Jun 9, 2020 | Bausch & Lomb Surgical, Inc. 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 correct Terminated |
HQL | None listed |
| Nov 5, 2018 | Bausch & Lomb Surgical, Inc. 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. T Terminated |
HQL | None listed |
| Apr 5, 2017 | Bausch & Lomb Surgical, Inc. 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 into the eye. The SofPort Easy-Load Lens Delivery System co Terminated |
MSS | K970727 |
| Jul 20, 2015 | Bausch & Lomb Surgical, Inc. Bausch & Lomb SoFlex SE Foldable intraocular Lens
Product Usage:
The SofPort/SoFlex IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia seco Terminated |
HQL | None listed |
| Jul 20, 2015 | Bausch & Lomb Surgical, Inc. Bausch & Lomb SofPort Advanced Optics Aspheric Lens Terminated |
HQL | None listed |
| Feb 20, 2014 | Bausch & Lomb Surgical, Inc. Bausch & Lomb AKREOS AO Micro Incision Lens
The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a catarac Terminated |
HQL | None listed |
| Jul 20, 2004 | Bausch & Lomb Surgical, Inc. SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens. Terminated |
HQL | None listed |