Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1281950

FEI Number

1281950

Entity Name

Bausch & Lomb Incorporated

City/State/Country

WILMINGTON, MA, US

Establishment Address

100 RESEARCH DRIVE, WILMINGTON, MA 01887, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bausch & Lomb Incorporated (Owner Number: 9913003)

Owner / Operator Contact Address

400 Somerset Corporate Blvd., --, Bridgewater, NJ 08807, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K183167

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MWL	Lens, Contact (Rigid Gas Permeable), Extended Wear	Ophthalmic	Class 3	886.5916	2005-08-01
NUU	Lens, Contact, Orthokeratology, Overnight	Ophthalmic	Class 3	886.5916	2005-08-01
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2008-01-09
MJP	Lens, Intraocular, Toric Optics	Ophthalmic	Class 3	886.3600	2008-01-17
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2008-01-17
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2008-01-09
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2008-01-09
MWL	Lens, Contact (Rigid Gas Permeable), Extended Wear	Ophthalmic	Class 3	886.5916	2008-01-09
HPX	Lens, Contact (Polymethylmethacrylate)	Unknown	Class U	N/A	2008-01-14
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2008-01-09
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2008-01-09
MUW	Lens, Contact (Orthokeratology)	Ophthalmic	Class 2	886.5916	2008-01-09
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2008-01-09
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2008-01-09
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2008-01-09
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2025-12-09
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2008-01-10
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2008-01-09
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2008-01-09
MUW	Lens, Contact (Orthokeratology)	Ophthalmic	Class 2	886.5916	2008-01-09
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	Class 2	886.5916	2023-01-19

Official Correspondent

Margaret Wood

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bausch & Lomb Incorporated

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1119279	Bausch & Lomb Incorporated	CLEARWATER, FL, US
1920664	Bausch & Lomb Incorporated	Saint Louis, MO, US
1032500	Bausch & Lomb Incorporated	GREENVILLE, SC, US
3007583964	TOTAL TITANIUM, INC.	Red Bud, IL, US
1315522	Bausch & Lomb Incorporated	Lancaster, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K963512	Benz Research and Development Corp.	BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL	1997-07-31
K820818	Bausch & Lomb, Inc.	CONCENTRATED CLEANER FOR HARD CONTACTS	1982-04-09
K813528	The Plactory	LENS-PAC	1982-01-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2022	Johnson & Johnson Surgical Vision Inc	3	TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile, disposable insertion system for delivering the IOL into the eye during cataract surgery.
Z-0275-2012	Abbott Medical Optics Inc (AMO)	3	Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.
Z-0276-2012	Abbott Medical Optics Inc (AMO)	3	Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.
Z-0605-2010	Abbott Medical Optics Inc (AMO)	3	AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)
Z-0929-2013	Abbott Medical Optics Inc (AMO)	3	AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.

Similar Registrations

Registration Number	Establishment Name	Location
3013398957	Paragon Vision Sciences, Inc.	Gilbert, AZ, US
1313525	Bausch & Lomb Incorporated	Rochester, NY, US
9614761	MENICON CO. LTD.	NAGOYA Aichi, JP
3005147469	ADVANCED VISION TECHNOLOGIES	Lakewood, CO, US
2031102	CONTEX, INCORPORATED	SHERMAN OAKS, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1281950. Last updated year: 2026. Please use registration number 1281950 when referencing this establishment in official correspondence.