Bausch & Lomb, Inc.
Bausch & Lomb, Inc. appears in FDA public data with 27 recalls, 104 510(k) clearances, 15 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-1396-2019, Class III) was initiated on June 17, 2019. Its most recent 510(k) clearance was granted on May 15, 2026.
Summary
- Total Recalls
- 27
- 510(k) Clearances
- 104
- Inspections
- 15
- Compliance Actions
- 0
Known Names
bausch and lomb, bausch and lomb incorporated, bausch and lomb surgical, bausch and lomb ireland limited, bausch and lomb, incorporated, bausch and lomb, inc, bausch and lomb de mexico, bausch and lomb brazil, bausch and lomb mexico sa de cv, bausch and lomb iom
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-1396-2019 | Class III | Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a div | June 17, 2019 |
| Z-3271-2018 | Class II | Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, | August 8, 2018 |
| Z-3265-2018 | Class II | Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, | August 8, 2018 |
| Z-3267-2018 | Class II | Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REF | August 8, 2018 |
| Z-3273-2018 | Class II | Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wide-Field Elite Pack, REF | August 8, 2018 |
| Z-3268-2018 | Class II | Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, | August 8, 2018 |
| Z-3266-2018 | Class II | Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF | August 8, 2018 |
| Z-3272-2018 | Class II | Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Field Elite Pack, REF | August 8, 2018 |
| Z-3275-2018 | Class II | Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide-Field Elite Pack, REF | August 8, 2018 |
| Z-3274-2018 | Class II | Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-Field Elite Pack, REF S | August 8, 2018 |
| Z-3269-2018 | Class II | Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite Pack, REF | August 8, 2018 |
| Z-3277-2018 | Class II | Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Field Elite Pack, REF | August 8, 2018 |
| Z-3276-2018 | Class II | Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-Field Elite Pack, REF S | August 8, 2018 |
| Z-3270-2018 | Class II | Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wide-Field Elite Pack, REF | August 8, 2018 |
| D-0899-2017 | Class II | NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88 FL OZ (26 m | June 6, 2017 |
| Z-0983-2017 | Class II | Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to | October 12, 2016 |
| D-0645-2016 | Class III | Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-73 | January 18, 2016 |
| D-0646-2016 | Class III | Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incor | January 18, 2016 |
| D-0647-2016 | Class III | Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 m | January 18, 2016 |
| D-1349-2015 | Class II | Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorpo | August 17, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K261264 | Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posteri | May 15, 2026 |
| K232084 | Stellaris Elite vision enhancement system | February 26, 2024 |
| K192005 | Bausch + Lomb PreVue Inserter for enVista Preloaded | October 4, 2019 |
| K173480 | Crystalsert Lens Delivery System | December 11, 2017 |
| K151102 | Bausch + Lomb Injector System | May 22, 2015 |
| K133486 | STELLARIS PC VISION ENHANCEMENT SYSTEM | March 12, 2014 |
| K133242 | STELLARIS VISION ENHANCEMENT SYSTEM | February 14, 2014 |
| K131958 | BAUSCH & LOMB INJECTOR SYSTEM | January 9, 2014 |
| K133146 | BAUSCH + LUMB, VIS100 INJECTOR SYSTEM | January 3, 2014 |
| K132481 | EASY-LOAD LENS DELIVERY SYSTEM | December 27, 2013 |
| K132593 | CRYSTALSERT DELIVERY SYSTEM | September 17, 2013 |
| K131208 | BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT | September 11, 2013 |
| K123736 | CRYSTALSERT DELIVERY SYSTEM | May 16, 2013 |
| K122575 | BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TOR | December 20, 2012 |
| K113852 | BAUSCH & LOMB IOL INJECTOR | September 28, 2012 |
| K112909 | OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION | April 30, 2012 |
| K111877 | EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION | January 24, 2012 |
| K112192 | NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS | October 25, 2011 |
| K101325 | STELLARIS PC VISION ENHANCEMENT SYSTEM | August 17, 2010 |
| K083757 | BPZ02 MULTIPURPOSE SOLUTION | November 18, 2009 |