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

Bausch & Lomb Incorporated: FDA-registered device maker in Saint Louis, MO, United States, 38 510(k) clearances and 1 PMA approval

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 1920664) in Saint Louis, MO, United States. It lists 27 device types. The FDA files 38 510(k) clearances and 1 PMA approval under its listings, the newest dated March 25, 2026. 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: 1920664
Address: 3365 Tree CT. Industrial BLVD., Saint Louis, MO, United States, 63122
Owner or operator: Bausch & Lomb Incorporated (9913003)
Roles: Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
First device listed: January 1, 1993
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Aberrometer, Ophthalmic	NCF	1	Remanufacturer	accessdata.fda.gov
Cannula, Trocar, Ophthalmic	NGY	1	Manufacturer	accessdata.fda.gov
Chisel, Middle-Ear	JYE	1	Manufacturer	accessdata.fda.gov
Collagen Corneal Shield	MOE	1	Manufacturer	accessdata.fda.gov
Device, Analysis, Anterior Segment	MXK	2	Remanufacturer	accessdata.fda.gov
Device, Irrigation, Ocular Surgery	KYG	1	Manufacturer	accessdata.fda.gov
Drape, Surgical, Antimicrobial	KKX	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Endoilluminator	MPA	2	Manufacturer, Specification developer	accessdata.fda.gov
Excimer Laser System	LZS	3	Remanufacturer	accessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2	Manufacturer	accessdata.fda.gov
Forceps, Ent	KAE	1	Manufacturer	accessdata.fda.gov
Illuminator, Fiberoptic, Surgical Field	HBI	2	Manufacturer	accessdata.fda.gov
Instrument, Vitreous Aspiration And Cutting, Ac-Powered	HQE	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Keratome, Ac-Powered	HNO	1	Remanufacturer	accessdata.fda.gov
Laser, Ophthalmic	HQF	2	Manufacturer	accessdata.fda.gov
Media, Corneal Storage	LYX	U	Manufacturer	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Manufacturer	accessdata.fda.gov
Needle, Aspiration And Injection, Reusable	GDM	1	Manufacturer	accessdata.fda.gov
Ophthalmic Femtosecond Laser	OOE	2	Remanufacturer	accessdata.fda.gov
Probe, Radiofrequency Lesion	GXI	2	Manufacturer	accessdata.fda.gov
Pump, Infusion, Ophthalmic	MRH	2	Manufacturer	accessdata.fda.gov
Rongeur, Nasal	KBB	1	Manufacturer	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer	accessdata.fda.gov
Trephine, Manual, Ophthalmic	HRH	1	Manufacturer	accessdata.fda.gov
Trocar, Ent	KTE	1	Manufacturer	accessdata.fda.gov
Unit, Phacofragmentation	HQC	2	Manufacturer, Repackager or relabeler	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
March 25, 2026	K252052	Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)	HQC	Substantially Equivalent	Bausch and Lomb, Incorporated	accessdata.fda.gov
July 26, 2024	K240169	Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)	HQC	Substantially Equivalent	Bausch and Lomb, Incorporated	accessdata.fda.gov
December 3, 2021	K211786	Independent Corneal Viewing Chamber (IVC-21)	LYX	Substantially Equivalent	Bausch + Lomb, Incorporated	accessdata.fda.gov
April 19, 2017	K170052	Stellaris Elite vision enhancement system	HQC	Substantially Equivalent	Bausch+Lomb	accessdata.fda.gov
March 24, 2017	K162342	Stellaris Elite Vision Enhancement System	HQC	Substantially Equivalent	Bausch+Lomb	accessdata.fda.gov
April 29, 2016	K153168	Bi-Blade Vitrectomy Cutter	HQE	Substantially Equivalent	Medical Instrument Development Laboratories	accessdata.fda.gov
January 28, 2016	K153186	Adjustable Fixation Device	MBI	Substantially Equivalent	Arthrocare Corp.	accessdata.fda.gov
January 16, 2015	K141379	VICTUS FEMTOSECOND LASER PLATFORM	OOE	Substantially Equivalent	Technolas Perfect Vision GmbH	accessdata.fda.gov
March 12, 2014	K133486	STELLARIS PC VISION ENHANCEMENT SYSTEM	HQC	Substantially Equivalent	Bausch & Lomb	accessdata.fda.gov
February 14, 2014	K133242	STELLARIS VISION ENHANCEMENT SYSTEM	HQC	Substantially Equivalent	Bausch & Lomb	accessdata.fda.gov
August 17, 2010	K101325	STELLARIS PC VISION ENHANCEMENT SYSTEM	HQC	Substantially Equivalent	Bausch & Lomb, Inc.	accessdata.fda.gov
August 28, 2008	K082132	BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK	HQC	Substantially Equivalent	Bausch & Lomb, Inc.	accessdata.fda.gov
December 19, 2006	K063331	BAUSCH & LOMB NGX MICROSURGICAL SYSTEM	HQC	Substantially Equivalent	Bausch & Lomb, Inc.	accessdata.fda.gov
August 16, 2004	K041998	PHACO CHOP NEEDLES	HQC	Substantially Equivalent	Bausch & Lomb, Inc.	accessdata.fda.gov
March 22, 2004	K040204	ZYOPTIX XP MICROKERATOME	HNO	Substantially Equivalent	Bausch & Lomb, Inc.	accessdata.fda.gov
February 10, 2004	K033941	MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK	HQF	Substantially Equivalent	Bausch & Lomb, Inc.	accessdata.fda.gov
June 19, 2002	K021640	HANSATOME EXCELLUS MICROKERATOME	HNO	Substantially Equivalent	Bausch & Lomb, Inc.	accessdata.fda.gov
March 5, 1999	K984443	ORBSCAN	MXK	Substantially Equivalent	Technolas Perfect Vision GmbH	accessdata.fda.gov
May 19, 1998	K980797	PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR	MPA	Substantially Equivalent	Peregrine Surgical , Ltd.	accessdata.fda.gov
June 17, 1997	K971439	STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES	HQC	Substantially Equivalent	Storz Instrument Co.	accessdata.fda.gov
November 25, 1996	K963434	VISCOUS FLUID SYSTEM	MRH	Substantially Equivalent	Escalon Trek Medical	accessdata.fda.gov
September 20, 1996	K960024	STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH	HQC	Substantially Equivalent	Storz Instrument Co.	accessdata.fda.gov
August 29, 1996	K960003	STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION	HQC	Substantially Equivalent	Storz Instrument Co.	accessdata.fda.gov
August 23, 1996	K962131	STORZ D4600 AIR EXCHANGE LINE PACK	HQC	Substantially Equivalent	Storz Instrument Co.	accessdata.fda.gov
June 27, 1996	K961310	STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)	HQC	Substantially Equivalent	Storz Instrument Co.	accessdata.fda.gov
March 26, 1996	K960007	STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR	MPA	Substantially Equivalent	Storz	accessdata.fda.gov
December 14, 1995	K954340	STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE	HQC	Substantially Equivalent	Storz	accessdata.fda.gov
October 27, 1995	K951463	STORZ I/A HANDPIECES	HQC	Substantially Equivalent	Storz Instrument Co.	accessdata.fda.gov
September 14, 1995	K953575	STORZ MVS-3201 VITRECTOMY PROBE PACK	HQE	Substantially Equivalent	Storz Instrument Co.	accessdata.fda.gov
July 26, 1995	K944872	BIO-COR COLLAGEN CORNEAL SHIELD	MOE	Substantially Equivalent	Bausch & Lomb Healthcare and Optics Worldwide	accessdata.fda.gov
June 2, 1995	K950114	STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM	HQC	Substantially Equivalent	Storz Instrument Co.	accessdata.fda.gov
November 28, 1994	K935926	STORZ PHACO AND FRAG HANDPIECES	HQC	Substantially Equivalent	Storz Instrument Co.	accessdata.fda.gov
April 11, 1994	K934445	STSTORZ DP5300 AND DP9502 STERILE DRAPES	KKX	Substantially Equivalent	Storz Instrument Co.	accessdata.fda.gov
June 9, 1992	K921728	DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIED	LYX	Substantially Equivalent	Chiron Intraoptics	accessdata.fda.gov
April 19, 1991	K904616	STORZ ULTRA-SOURCE HIGH OUTPUT ILLUMINATOR	HBI	Substantially Equivalent	Storz Instrument Co.	accessdata.fda.gov
February 15, 1990	K896549	STORZ FIBEROPTIC ENDO-ILLUMINATORS	HBI	Substantially Equivalent	Storz Instrument Co.	accessdata.fda.gov
March 17, 1988	K880293	THE STORZ BIPOLAR PENCIL AND CORD	GXI	Substantially Equivalent	Storz Instrument Co.	accessdata.fda.gov
October 6, 1987	K870051	SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE	CAF	Substantially Equivalent	Viratek, Inc.	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
February 23, 2000	P990027	TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z)	LZS	23	February 6, 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
August 8, 2018	80837	Class II	Terminated	Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.	The back cap separates from the body of the vitrectomy cutter.	accessdata.fda.gov
November 4, 2014	69717	Class II	Terminated	Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY	A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use.	accessdata.fda.gov

Compare with other makers

Updated March 25, 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.