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

Bausch & Lomb Incorporated: FDA-registered device maker in Lynchburg, VA, United States, 9 510(k) clearances and 5 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 1123818) in Lynchburg, VA, United States. It lists 5 device types. The FDA files 9 510(k) clearances and 5 PMA approvals under its listings, the newest dated June 2, 2020. 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: 1123818
FEI number: 1000305478
Address: 1501 Graves Mill Rd, Lynchburg, VA, United States, 24502
Owner or operator: Bausch & Lomb Incorporated (9913003)
Roles: Manufacturer
First device listed: May 12, 2006
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Lens, Contact (Other Material) - Daily	HQD	2	Manufacturer	accessdata.fda.gov
Lens, Contact (Polymethylmethacrylate)	HPX	U	Manufacturer	accessdata.fda.gov
Lens, Contact, (Disposable)	MVN	2	Manufacturer	accessdata.fda.gov
Lenses, Soft Contact, Daily Wear	LPL	2	Manufacturer	accessdata.fda.gov
Lenses, Soft Contact, Extended Wear	LPM	3	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
June 2, 2020	K200528	Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism	LPL	Substantially Equivalent	Bausch + Lomb, Incorporated	accessdata.fda.gov
November 30, 2018	K182249	Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens	LPL	Substantially Equivalent	Bausch & Lomb, Incorporated	accessdata.fda.gov
February 13, 2015	K143632	Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens	LPL	Substantially Equivalent	Bausch & Lomb, Incorporated	accessdata.fda.gov
December 20, 2013	K132715	BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS	LPL	Substantially Equivalent	Bausch & Lomb, Incorporated	accessdata.fda.gov
September 11, 2013	K131208	BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,	LPL	Substantially Equivalent	Bausch & Lomb, Inc.	accessdata.fda.gov
June 5, 2012	K113703	BAUSCH + LOMB NESOFILCON A CONTACT LENS	LPL	Substantially Equivalent	Bausch & Lomb, Incorporated	accessdata.fda.gov
June 10, 2008	K080755	SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS	MVN	Substantially Equivalent	Bausch & Lomb, Inc.	accessdata.fda.gov
June 22, 2006	K061157	SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS	MVN	Substantially Equivalent	Bausch & Lomb	accessdata.fda.gov
May 16, 2002	K020927	BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS	LPL	Substantially Equivalent	Bausch & Lomb	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
April 30, 2018	P170035	Bausch + Lomb Ultra (samfilcon A) Contact Lenses	LPM	18	September 14, 2026	accessdata.fda.gov
February 5, 1999	P980006	PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR	LPM	35	March 17, 2025	accessdata.fda.gov
December 16, 1996	P960022	SOFLENS66(TM)	LPM	13	April 8, 2025	accessdata.fda.gov
December 31, 1985	P850068	SILSOFT (ELASTOFILCON A) CONTACT LENSES	LPM	14	March 18, 2022	accessdata.fda.gov
March 18, 1971	N16895	SOFLENS CONTACT LENSES (POLYMACON)	LPM	96	October 24, 2025	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
October 12, 2016	75915	Class II	Terminated	Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient	According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of SKU 0816 C (Pterygium Burr Medium Diamond). Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operati	accessdata.fda.gov
August 25, 2003	27058	Not yet classified	Terminated	Microflow Needles, catalog #DP8200, with 0 degree tapering, labeled in part *Non-sterile, Manufactured for Bausch and Lomb, Inc. Rochester, NY 14609*, packaged 6 needles/box.	The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.	accessdata.fda.gov

Compare with other makers

Updated September 14, 2026. 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.