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Bausch & Lomb Ireland Limited T/A Bausch and Lomb Ireland: FDA-registered device maker in WATERFORD Munster, Ireland, 8 510(k) clearances and 2 PMA approvals

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

Bausch & Lomb Ireland Limited T/A Bausch and Lomb Ireland is registered with the FDA (registration 9610731) in WATERFORD Munster, Ireland. It lists 3 device types. The FDA files 8 510(k) clearances and 2 PMA approvals under its listings, the newest dated May 24, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9610731
FEI number: 3002806454
Address: Unit 424/425, Contact Lens Division Industrial Estate, Cork RD, WATERFORD Munster, Ireland, --
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, (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
May 24, 2021	K210975	Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia	LPL	Substantially Equivalent	Bausch & Lomb, Incorporated	accessdata.fda.gov
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
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
June 5, 2012	K113703	BAUSCH + LOMB NESOFILCON A CONTACT LENS	LPL	Substantially Equivalent	Bausch & Lomb, Incorporated	accessdata.fda.gov
October 25, 2011	K112192	NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS	MVN	Substantially Equivalent	Bausch & Lomb, Inc.	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

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
December 16, 1996	P960022	SOFLENS66(TM)	LPM	13	April 8, 2025	accessdata.fda.gov
March 18, 1971	N16895	SOFLENS CONTACT LENSES (POLYMACON)	LPM	96	October 24, 2025	accessdata.fda.gov

Compare with other makers

Updated April 8, 2025. 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.