Data / Medical devices / United States / Bausch & Lomb Incorporated

Bausch & Lomb Incorporated: FDA-registered device maker in Greenville, SC, United States, 15 510(k) clearances and 6 PMA approvals

Name: Bausch & Lomb Incorporated FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bausch & Lomb Incorporated is registered with the FDA (registration 1032500) in Greenville, SC, United States. It lists 3 device types. The FDA files 15 510(k) clearances and 6 PMA approvals under its listings, the newest dated December 6, 2022. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1032500
Address: 8507 Pelham RD., Greenville, SC, United States, 29615
Owner or operator: Bausch & Lomb Incorporated (9913003)
Roles: Manufacturer
First device listed: January 10, 2008
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Soft Lens Products	LPN	2	Manufacturer	accessdata.fda.gov
Accessories, Solution, Ultrasonic Cleaners For Lenses	LYL	2	Manufacturer	accessdata.fda.gov
Products, Contact Lens Care, Rigid Gas Permeable	MRC	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 6, 2022	K222541	Bausch + Lomb Preservative Free Lubricating and Rewetting Drops	LPN	Substantially Equivalent	Bausch & Lomb, Incorporated	accessdata.fda.gov
May 28, 2021	K202932	ABT12 multi-purpose solution	LPN	Substantially Equivalent	Bausch & Lomb, Incorporated	accessdata.fda.gov
August 10, 2018	K181627	Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner	MRC	Substantially Equivalent	Bausch & Lomb, Incorporated	accessdata.fda.gov
March 27, 2018	K180319	Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution	MRC	Substantially Equivalent	Bausch and Lomb, Incorporated	accessdata.fda.gov
November 27, 2017	K173089	Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions	MRC	Substantially Equivalent	Bausch & Lomb, Incorporated	accessdata.fda.gov
April 11, 2017	K170483	Bausch + Lomb Sensitive Eyes Plus Saline Solution	LPN	Substantially Equivalent	Bausch & Lomb, Incorporated	accessdata.fda.gov
November 25, 2016	K161819	NNR06 Multi-Purpose Solution	LPN	Substantially Equivalent	Bausch & Lomb, Incorporated	accessdata.fda.gov
November 18, 2009	K083757	BPZ02 MULTIPURPOSE SOLUTION	LYL	Substantially Equivalent	Bausch & Lomb, Inc.	accessdata.fda.gov
May 2, 2003	K024289	BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION	MRC	Substantially Equivalent	Bausch & Lomb, Incorporated	accessdata.fda.gov
April 20, 2000	K000247	BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER	LPN	Substantially Equivalent	Bausch & Lomb, Inc.	accessdata.fda.gov
June 24, 1998	K980591	RENU MULTIPLUS LUBRICATING & REWETTING DROPS	LPN	Substantially Equivalent	Bausch & Lomb, Inc.	accessdata.fda.gov
March 11, 1998	K980133	BAUSCH & LOMB WETTING AND SOAKING SOLUTION	LPN	Substantially Equivalent	Polymer Technology Corp.	accessdata.fda.gov
March 10, 1998	K974723	RENU MULTIPLUS MULTI-PURPOSE SOLUTION	LPN	Substantially Equivalent	Bausch & Lomb, Inc.	accessdata.fda.gov
February 19, 1998	K974466	BOSTON ADVANCE CLEANER	MRC	Substantially Equivalent	Polymer Technology Corp.	accessdata.fda.gov
November 24, 1997	K973217	BOSTON LIQUID ENZYMATIC CLEANER	LPN	Substantially Equivalent	Polymer Technology Corp.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
July 14, 1988	P860023	SENSITIVE EYES CLEANING/DISINFECTING SOLUTION	LPN	9	July 3, 1997	accessdata.fda.gov
June 11, 1987	P830013	B&L SENSITIVE EYES(TM) DAILY CLEANER	LPN	5	April 13, 1994	accessdata.fda.gov
March 29, 1984	P820070	BOSTON LENS(R) CONDITIONING SOLUTION	LPN	14	July 13, 1990	accessdata.fda.gov
March 19, 1984	P820031	SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION	LPN	11	March 10, 1997	accessdata.fda.gov
March 16, 1984	P820069	BOSTON LENS(R) CLEANER	LPN	12	August 15, 1994	accessdata.fda.gov
July 31, 1981	P800024	BAUSCH & LOMB STERILE PRESERVED SALINE SOLUTION	LPN	16	May 5, 1995	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 25, 2014	69347	Class II	Terminated	Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 fl. oz. (355 mL), Distributed by Walmart Stores, Inc.	Product lot did not meet the specification for its disinfectants at the time of manufacture.	accessdata.fda.gov
April 21, 2014	68095	Class II	Terminated	Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.	Out of specification results for one of the two disinfectants.	accessdata.fda.gov

Compare with other makers

Updated December 6, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.