Company · US
Bausch and Lomb, Incorporated
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (2 in 12 months)
2recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 15, 2026 | K261264 | Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE54 Bausch and Lomb | HQC |
| Mar 25, 2026 | K252052 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) Bausch and Lomb, Incorporated | HQC |
| Jul 26, 2024 | K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) Bausch and Lomb, Incorporated | HQC |
| Feb 26, 2024 | K232084 | Stellaris Elite vision enhancement system Bausch and Lomb | HQC |
| Mar 27, 2018 | K180319 | Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution Bausch and Lomb, Incorporated | MRC |
| Jul 6, 2016 | K161012 | Easy-Load Lens Delivery System Bausch and Lomb, Inc., | MSS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2013 | Bausch and Lomb, Incorporated Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 6005 Terminated |
HMX | None listed |
| Jan 11, 2012 | Bausch and Lomb, Incorporated Crystalens Accommodating Posterior Chamber Intraocular Lens, AT-50AO.
Crystalens Accommodating Posterior Chamber Intraocular Lens
PMA No.: P030002.
The Crystalens is intended for primary implantatio Terminated |
NAA | None listed |