Data / Medical devices / United States / Alcon Research, LLC

Alcon Research, LLC: FDA-registered device maker in Lesage, WV, United States, 2 510(k) clearances and 5 PMA approvals

Name: Alcon Research, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Alcon Research, LLC is registered with the FDA (registration 3007530141) in Lesage, WV, United States. It lists 6 device types. The FDA files 2 510(k) clearances and 5 PMA approvals under its listings, the newest dated January 7, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007530141
Address: 2 Vision Lane, Lesage, WV, United States, 25537
Owner or operator: Alcon Laboratories, Inc. (1610287)
Roles: Manufacturer, Manufacturer for export
First device listed: February 28, 2006
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Extended Depth Of Focus Intraocular Lens	POE	3	Manufacturer, Manufacturer for export	accessdata.fda.gov
Folders And Injectors, Intraocular Lens (Iol)	MSS	1	Manufacturer	accessdata.fda.gov
Intraocular Lens	HQL	3	Manufacturer	accessdata.fda.gov
Lens, Guide, Intraocular	KYB	1	Manufacturer	accessdata.fda.gov
Lens, Intraocular, Toric Optics	MJP	3	Manufacturer, Manufacturer for export	accessdata.fda.gov
Lens, Multifocal Intraocular	MFK	3	Manufacturer, Manufacturer for export	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 27, 2007	K063155	MONARCH III IOL DELIVERY SYSTEM	KYB	Substantially Equivalent	Alcon Manufacturing, Ltd.	accessdata.fda.gov
January 5, 2001	K003768	MONARCH II IOL DELIVERY SYSTEM	MSS	Substantially Equivalent	Alcon Research, Ltd.	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
January 7, 2020	P190018	Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens	HQL	49	August 17, 2026	accessdata.fda.gov
March 21, 2005	P040020	ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL	MFK	118	July 6, 2026	accessdata.fda.gov
December 22, 1994	P930014	ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES	HQL	161	July 8, 2026	accessdata.fda.gov
January 31, 1990	P880087	KELMAN MULTIFLEX 2 MODELS: MT3-MT7 & MT2U-MT7U	HQL	30	June 20, 2024	accessdata.fda.gov
April 30, 1986	P840060	SM-1, CR-1, & GR-1 IOLS	HQL	45	June 20, 2024	accessdata.fda.gov

Compare with other makers

Updated August 17, 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.