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

Alcon Research, LLC: FDA-registered device maker in Houston, TX, United States, 12 510(k) clearances

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 1644019) in Houston, TX, United States. It lists 18 device types. The FDA files 12 510(k) clearances under its listings, the newest dated December 4, 2024. 12 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1644019
FEI number: 1000117501
Address: 9965 Buffalo Speedway, Houston, TX, United States, 77054
Owner or operator: Alcon Laboratories, Inc. (1610287)
Roles: Manufacturer
First device listed: April 16, 2002
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Cautery, Radiofrequency, Ac-Powered	HQR	2	Manufacturer	accessdata.fda.gov
Cannula, Trocar, Ophthalmic	NGY	1	Manufacturer	accessdata.fda.gov
Device, Irrigation, Ocular Surgery	KYG	1	Manufacturer	accessdata.fda.gov
Drape, Patient, Ophthalmic	HMT	2	Manufacturer	accessdata.fda.gov
Endoilluminator	MPA	2	Manufacturer	accessdata.fda.gov
Eye Tray	OJK	2	Manufacturer	accessdata.fda.gov
General Surgery Tray	LRO	2	Manufacturer	accessdata.fda.gov
Instrument, Vitreous Aspiration And Cutting, Ac-Powered	HQE	2	Manufacturer	accessdata.fda.gov
Iol Tray	QDV	1	Manufacturer	accessdata.fda.gov
Keratome, Ac-Powered	HNO	1	Manufacturer	accessdata.fda.gov
Laser, Ophthalmic	HQF	2	Manufacturer	accessdata.fda.gov
Lens, Guide, Intraocular	KYB	1	Manufacturer	accessdata.fda.gov
Ophthalmic Femtosecond Laser	OOE	2	Manufacturer	accessdata.fda.gov
Phaco Kit	QDW	2	Manufacturer	accessdata.fda.gov
Surgical Eye Tray	PZG	1	Manufacturer	accessdata.fda.gov
Unit, Phacofragmentation	HQC	2	Manufacturer	accessdata.fda.gov
Vitrectomy Kit	QDY	2	Manufacturer	accessdata.fda.gov
Vitrectomy, Instrument Cutter	MLZ	2	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
December 4, 2024	K242184	Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);	MPA	Substantially Equivalent	Alcon Laboratories, Inc.	accessdata.fda.gov
June 21, 2024	K233876	UNITY VCS (8065000296); UNITY CS (8065000297)	HQC	Substantially Equivalent	Alcon Laboratories, Inc.	accessdata.fda.gov
January 10, 2024	K233902	Centurion Vision System (Active Sentry) (8065753057)	HQC	Substantially Equivalent	Alcon Laboratories, Inc.	accessdata.fda.gov
November 1, 2019	K191650	LEGION System	HQC	Substantially Equivalent	Alcon Research, LLC	accessdata.fda.gov
March 27, 2018	K173660	LenSx Laser System	OOE	Substantially Equivalent	Alcon Laboratories, Inc.	accessdata.fda.gov
March 22, 2017	K170520	HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+	MLZ	Substantially Equivalent	Alcon Research, Ltd.	accessdata.fda.gov
August 22, 2014	K141065	CONSTELLATION VISION SYSTEM	HQE	Substantially Equivalent	Alcon Research, Ltd.	accessdata.fda.gov
November 21, 2011	K112425	INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE	HQC	Substantially Equivalent	Alcon Manufacturing, Ltd.	accessdata.fda.gov
April 2, 2010	K093305	ENHANCED ULTRA VIT PROBE	MLZ	Substantially Equivalent	Alcon Research, Ltd.	accessdata.fda.gov
July 2, 2002	K021566	INFINITI	HQC	Substantially Equivalent	Alcon Laboratories, Inc.	accessdata.fda.gov
April 29, 1988	K880961	ALCON SURGICAL PROCEDURE PACKS	LRO	Substantially Equivalent	Alcon Laboratories	accessdata.fda.gov
April 6, 1983	K830822	EYE DRAPE	HMT	Substantially Equivalent	CooperVision, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 15, 2024	94253	Class II	Ongoing	Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of ophthalmic surgeries. The	Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas.	accessdata.fda.gov
February 21, 2024	94094	Class II	Ongoing	SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16, 15190-16, 15190-16, 15190-16, 15190-16, 13554-1	Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical procedure packs that were subsequently terminally sterilized, so after the packs are opened, syringes should be discarded at surgical case end, and not reshelved, because the use of non-sterile bulb irrigatio	accessdata.fda.gov
September 7, 2023	93115	Class II	Ongoing	Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR	Custom surgical procedure packs contain latex gloves but are labeled as "latex free".	accessdata.fda.gov
March 10, 2023	91878	Class II	Ongoing	Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-03 DR GEORGE ZAMBELLI BEAVER VALLEY ASC 8685-21 CATARACT PACK EYE SURGICAL CNTR OF AR 1	Sterility; Steril surgical procedure packs contain incomplete seals.	accessdata.fda.gov
October 31, 2022	91105	Class II	Ongoing	Alcon Custom Pak Surgical Procedure Pack	Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. In addition, the manufacturer of the drapes has observed an increase in reported adhesive related skin injuries for these affected lots.	accessdata.fda.gov
June 9, 2022	90437	Class II	Ongoing	Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL WOOTTON EYE INSTITUTE 18527-03 14JM57 DOSS CATARACT ALLIANCE EYE SURG PARTNERS 11802-07	Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.	accessdata.fda.gov
February 2, 2021	87307	Class II	Terminated	Alcon Custom Ophthalmic Surgical Procedure Packs	Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages.	accessdata.fda.gov
August 24, 2020	86315	Class II	Terminated	Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.	The third-party brand latex micro surgical gloves packaged within specific custom packs may have a degradation defect that could lead to holes and donning tears at the folding area around the cuffs. This could increase the potential risk of infection or cross-patient (clinician) exposure to body fluids.	accessdata.fda.gov
January 12, 2018	79226	Class II	Terminated	Alcon 25+ TOT ALPLUS Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.	Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+ TOTALPLUS Vitrectomy Pak due a potential that a 23GA ULTRAVIT probe may be included within the 25+ TOTALPLUS Vitrectomy Pak, instead of a 25+ ULTRAVIT probe.	accessdata.fda.gov
August 8, 2017	77965	Class II	Terminated	Alcon Custom Pak	Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks.	accessdata.fda.gov
May 29, 2012	62419	Class II	Terminated	This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, A	This medical device correction is related to Alcon products that present a 23G non-valved trocar cannula and infusion cannula together because of an issue regarding the loose fit between the 23G non-valved trocar cannula and infusion cannula that could potentially cause a detachment between the non-valved trocar cannula and infusion cannula during surgery.	accessdata.fda.gov
December 22, 2006	37153	Not yet classified	Terminated	Alcon Custom-Pak, part #10975-02, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston,	Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.	accessdata.fda.gov

Compare with other makers

Updated December 4, 2024. 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.