Data / Medical devices / Lenses, Soft Contact, Extended Wear

Lenses, Soft Contact, Extended Wear (LPM): 15 FDA-registered makers in 6 countries

Name: FDA-registered makers of Lenses, Soft Contact, Extended Wear
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

15 establishments in 6 countries are registered with the FDA to make Lenses, Soft Contact, Extended Wear (product code LPM, Class 3, 21 CFR 886.5925). 15 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 18 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: LPM
Device class: 3
Regulation: 886.5925
Medical specialty: Ophthalmic

Makers by country

Country	Makers
United States	9
Ireland	2
Germany	1
Malaysia	1
United Kingdom	1
Indonesia	1

Makers of Lenses, Soft Contact, Extended Wear

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	PMA approvals	Recall events	Source
Bausch & Lomb Incorporated	Rochester, NY, United States	Complaint file establishment, Manufacturer, Specification developer	5	1	api.fda.gov
Bausch & Lomb Incorporated	Lynchburg, VA, United States	Manufacturer	5	0	api.fda.gov
Alcon Research, LLC	Duluth, GA, United States	Repackager or relabeler, Specification developer	2	5	api.fda.gov
Alcon Research, LLC	Fort Worth, TX, United States	Specification developer	2	0	api.fda.gov
Bausch & Lomb Ireland Limited T/A Bausch and Lomb Ireland	WATERFORD Munster, Ireland	Manufacturer	2	0	api.fda.gov
Ciba Vision GMBH	GROSSWALLSTADT Bavaria, Germany	Exporter to the US, Manufacturer	2	0	api.fda.gov
COOPERVISION Manufacturing Puerto Rico, LLC	Juana Diaz, PR, United States	Complaint file establishment, Manufacturer	2	1	api.fda.gov
Coopervision, Inc.	Scottsville, NY, United States	Complaint file establishment, Manufacturer	2	1	api.fda.gov
Johnson & Johnson Vision Care Ireland Unlimited Company	. Limerick(County), Ireland	Manufacturer	2	0	api.fda.gov
Johnson & Johnson Vision Care, Inc.	Jacksonville, FL, United States	Manufacturer	2	2	api.fda.gov
Bausch & Lomb Incorporated	Clearwater, FL, United States	Manufacturer	1	0	api.fda.gov
Ciba Vision Johor SDN.BHD.	Gelang Patah, Johor Darul Takzim, Malaysia	Manufacturer, Repackager or relabeler	1	0	api.fda.gov
Coopervision Manufacturing, Ltd.	SOUTHAMPTON Hampshire, United Kingdom	Complaint file establishment, Manufacturer	1	0	api.fda.gov
Kontur Kontact Lens Co., Inc.	Hercules, CA, United States	Manufacturer	1	0	api.fda.gov
PT. Ciba Vision Batam	BATAM ISLAND Riau, Indonesia	Manufacturer	1	0	api.fda.gov

Updated November 2, 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.