Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610731

FEI Number

3002806454

Entity Name

Bausch & Lomb Ireland Limited T/A Bausch and Lomb Ireland

City/State/Country

WATERFORD Munster, IE

Establishment Address

UNIT 424/425, CONTACT LENS DIVISION, INDUSTRIAL ESTATE, CORK RD, WATERFORD Munster --, IE

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

N/A

PMA Number

N16895

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
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2014-05-19
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2014-05-19
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2012-06-13
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2012-06-13
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2008-10-21
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2016-08-26
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2016-08-26
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2006-05-12
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2012-05-23
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2020-08-06
MVN	Lens, Contact, (Disposable)	Ophthalmic	Class 2	886.5925	2020-08-06
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2008-01-02
LPM	Lenses, Soft Contact, Extended Wear	Ophthalmic	Class 3	886.5925	2008-01-02

Official Correspondent

Margaret Wood

US Agent Details

Margaret Wood Business: BAUSCH & LOMB INCORPORATED Email: FDADeviceReg@bausch.com Phone: (864) 3206017

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
1281950	Bausch & Lomb Incorporated	WILMINGTON, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K133079	Alden Optical Labs., Inc.	IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)	2013-12-17
K941998	Ocu-Ease Optical Products, Inc.	OCU-FLEX-38 (POLYMACON)	1994-10-13
K992500	Cantor & Silver , Ltd.	CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS	1999-08-18
K984098	Adventures IN Color Technology, Ltd.	ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS	1999-05-10
K003161	Les Laboratoires Blanchard	ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT	2000-12-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0018-07	Ciba Vision Corporation	2	CSI Daily Wear, soft (hydrophilic) contact lenses
Z-0019-07	Ciba Vision Corporation	2	CSI Flexible Wear, soft (hydrophilic) contact lenses
Z-0020-07	Ciba Vision Corporation	2	CSI Toric, soft (hydrophilic) contact lenses
Z-0044-2012	CooperVision Inc.	2	AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES FOR ASTIGMATISM, CooperVision, Scottsville, NY 14546 USA; Juana Diaz, PR 00795 USA; Hamble SO31, 4RF, UK; Device Listing # D033736. Product Usage: Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00- to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. The AVAIRA Soft Contact Lens is indicated for single - use disposable wear and daily wear. When prescribed for frequent replacement, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.
Z-0326-2026	Alcon Research LLC	2	Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610731. Last updated year: 2026. Please use registration number 9610731 when referencing this establishment in official correspondence.