Bausch and Lomb, Incorporated
FDA Regulatory Profile
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 25
- Inspections
- 8
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0672-2013 | Class I | Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( M | November 15, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K242389 | EyeGility Inserter for Preloaded enVista IOLs | October 10, 2024 |
| K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) | July 26, 2024 |
| K220613 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hyd | March 8, 2023 |
| K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting Drops | December 6, 2022 |
| K202932 | ABT12 multi-purpose solution | May 28, 2021 |
| K210975 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia | May 24, 2021 |
| K200416 | Boston One Step Liquid Enzymatic Cleaner | September 23, 2020 |
| K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permea | February 12, 2019 |
| K182249 | Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens | November 30, 2018 |
| K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cl | August 10, 2018 |
| K180319 | Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution | March 27, 2018 |
| K173089 | Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions | November 27, 2017 |
| K173365 | Bausch + Lomb Boston Scleral Lens Case | November 17, 2017 |
| K170483 | Bausch + Lomb Sensitive Eyes Plus Saline Solution | April 11, 2017 |
| K161819 | NNR06 Multi-Purpose Solution | November 25, 2016 |
| K151918 | Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for As | February 11, 2016 |
| K143632 | Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens | February 13, 2015 |
| K132715 | BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS | December 20, 2013 |
| K132216 | BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION | September 9, 2013 |
| K113703 | BAUSCH + LOMB NESOFILCON A CONTACT LENS | June 5, 2012 |