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Bausch & Lomb, Inc.

FDA Regulatory Profile

Summary

Total Recalls
27
510(k) Clearances
103
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 iom, bausch and lomb india private, bausch and lomb americas, bausch and lomb de mexico

Recent Recalls

NumberClassProductDate
D-1396-2019Class IIILotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a divJune 17, 2019
Z-3268-2018Class IIBausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches,August 8, 2018
Z-3269-2018Class IIBausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite Pack, REF August 8, 2018
Z-3267-2018Class IIBausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REFAugust 8, 2018
Z-3265-2018Class IIBausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches,August 8, 2018
Z-3277-2018Class IIBausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Field Elite Pack, REF August 8, 2018
Z-3270-2018Class IIBausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wide-Field Elite Pack, REFAugust 8, 2018
Z-3272-2018Class IIBausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Field Elite Pack, REF August 8, 2018
Z-3266-2018Class IIBausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF August 8, 2018
Z-3275-2018Class IIBausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide-Field Elite Pack, REF August 8, 2018
Z-3276-2018Class IIBausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-Field Elite Pack, REF SAugust 8, 2018
Z-3271-2018Class IIBausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches,August 8, 2018
Z-3273-2018Class IIBausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wide-Field Elite Pack, REFAugust 8, 2018
Z-3274-2018Class IIBausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-Field Elite Pack, REF SAugust 8, 2018
D-0899-2017Class IINasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88 FL OZ (26 mJune 6, 2017
Z-0983-2017Class IIAlgerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to October 12, 2016
D-0645-2016Class IIICyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-73January 18, 2016
D-0646-2016Class IIITropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb IncorJanuary 18, 2016
D-0647-2016Class IIITropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mJanuary 18, 2016
D-1349-2015Class IIBromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb IncorpoAugust 17, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K232084Stellaris Elite vision enhancement systemFebruary 26, 2024
K192005Bausch + Lomb PreVue Inserter for enVista PreloadedOctober 4, 2019
K173480Crystalsert Lens Delivery SystemDecember 11, 2017
K151102Bausch + Lomb Injector SystemMay 22, 2015
K133486STELLARIS PC VISION ENHANCEMENT SYSTEMMarch 12, 2014
K133242STELLARIS VISION ENHANCEMENT SYSTEMFebruary 14, 2014
K131958BAUSCH & LOMB INJECTOR SYSTEMJanuary 9, 2014
K133146BAUSCH + LUMB, VIS100 INJECTOR SYSTEMJanuary 3, 2014
K132481EASY-LOAD LENS DELIVERY SYSTEMDecember 27, 2013
K132593CRYSTALSERT DELIVERY SYSTEMSeptember 17, 2013
K131208BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT September 11, 2013
K123736CRYSTALSERT DELIVERY SYSTEMMay 16, 2013
K122575BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORDecember 20, 2012
K113852BAUSCH & LOMB IOL INJECTORSeptember 28, 2012
K112909OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTIONApril 30, 2012
K111877EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTIONJanuary 24, 2012
K112192NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENSOctober 25, 2011
K101325STELLARIS PC VISION ENHANCEMENT SYSTEMAugust 17, 2010
K083757BPZ02 MULTIPURPOSE SOLUTIONNovember 18, 2009
K082473BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEMJanuary 5, 2009