FDA.reportPublic FDA data

ALCON LABORATORIES IRELAND LTD.

Matched from indexed company URL: Alcon Laboratories

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96121693002808262ALCON LABORATORIES IRELAND LTD.1N2026-01-01CORK BUSINESS AND TECHNOLOGY PARK MODEL FARM RD. CORK IE -
30154569513015456951Alcon Laboratories Belgium1N2026-01-01Lichterveld 3 Puurs-Sint-Amands Antwerpen BE 2870

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00380652268899ACRYSOF, IQ RESTOR - Acrysof IQ ReStor Multifocal Toric IOL; STERILE UV and Blue Light Filtering Acrylic Foldable; Apodized Diffractive Aspheric Multifocal Toric Posterior Chamber Intraocular Lens; IOL Cylinder Power 1.50+1(800)862-5266web.masterus@alcon.com
00380657402601Alcon - Straight Pick Fiber Optic, Regular, 2.1m+1(800)862-5266web.masterus@alcon.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2271121955590107P990023CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICELZP2000-02-24
1753471846033250P930014ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSESHQL1994-12-22
2271121846033250P930014ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSESHQL1994-12-22
2271121983976184P890047PROVISC(TM)VISCOELASTIC PREPARATIONLZP1991-09-26
2271121061909259P840064VISCOAT(TM)/DVOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICESLZP1986-04-30
2271121765131769P190018Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular LensHQL2020-01-07
1753471765131769P190018Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular LensHQL2020-01-07
1753471102870917P040020ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOLMFK2005-03-21
2271121102870917P040020ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOLMFK2005-03-21
2271121106040295P010059MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14CMRJ2003-10-23
2271121256789625K911808GEMINI OPHTHALMIC SURGERY SYSTEMHQC1991-06-25
2271121303986311K884043GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGEHQE1988-11-16
2271122028678474K11095127+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULAHQB2011-10-17
2271121598304694K101285CONSTELLATION VISION SYSTEMHQC2010-11-12
2271121605824007K063583ALCON VISION SYSTEMHQC2008-05-09
2271121165150667K021566INFINITIHQC2002-07-02
2271121607066027K012852EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONSKYF2002-03-26
1753471033489139
1753471129209485
2271121033489139
2271121047334031
2271121129209485
2271121193396585
2271121228529572
2271121255023867
2271121447176341
2271121674469855
2271121710171096

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HQC42010-11-12
MFK22005-03-21
HQL21994-12-22
LZP21991-09-26
HQB12011-10-17
MRJ 12003-10-23
KYF12002-03-26
LZP 12000-02-24
HQE11988-11-16

NDC#

MIOSTAT

Alcon Laboratories, Inc.

carbachol

Naphcon A

Alcon Laboratories, Inc.

naphazoline hydrochloride and pheniramine maleate

Cyclomydril

Alcon Laboratories, Inc.

cyclopentolate hydrochloride and phenylephrine hydrochloride

Cyclogyl

Alcon Laboratories, Inc.

cyclopentolate hydrochloride

Cyclogyl

Alcon Laboratories, Inc.

cyclopentolate hydrochloride

Cyclogyl

Alcon Laboratories, Inc.

cyclopentolate hydrochloride

Betadine

Alcon Laboratories, Inc.

povidone-iodine

BION TEARS

Alcon Laboratories, Inc.

Dextran, Hypromellose

Systane Lubricant

Alcon Laboratories, Inc.

polyethylene glycol 400 and Propylene Glycol

Systane

Alcon Laboratories, Inc.

polyethylene glycol 400 and propylene glycol

Systane

Alcon Laboratories, Inc.

hypromellose

GenTeal

Alcon Laboratories, Inc.

mineral oil, white petrolatum

BSS

Alcon Laboratories, Inc.

balanced salt solution

BSS PLUS

Alcon Laboratories, Inc.

balanced salt solution enriched with bicarbonate, dextrose, and glutathione

BSS PLUS

Alcon Laboratories, Inc.

balanced salt solution enriched with bicarbonate, dextrose, and glutathione

Systane Ultra

Alcon Laboratories, Inc.

Polyethylene Glycol 400 and Propylene Glycol

Systane

Alcon Laboratories, Inc.

polyethylene glycol 400 and propylene glycol

BSS

Alcon Laboratories, Inc.

balanced salt solution

Zaditor

Alcon Laboratories, Inc.

ketotifen fumarate

SIMBRINZA

Alcon Laboratories, Inc.

brinzolamide/brimonidine tartrate

55 records. Showing 1-40. Next

PMA#

AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems

2022-12-20

ALCON LABORATORIES, INC.6201 South Freeway Dr.fort Worth, TX 76134 PMA NumberP930014 Supplement NumberS144 Date Received11/22/2022 Decision Date12/20/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process...

CELLUGEL® Ophthalmic Viscosurgical s

2022-09-22

ALCON LABORATORIES6201 South Freewayfort Worth, TX 76134 PMA NumberP990023 Supplement NumberS018 Date Received08/24/2022 Decision Date09/22/2022 Product Code LZP  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - ...

CELLUGEL OVD

2022-09-15

ALCON LABORATORIES6201 South Freewayfort Worth, TX 76134 PMA NumberP990023 Supplement NumberS017 Date Received08/23/2022 Decision Date09/15/2022 Product Code LZP  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - ...

Perfluoron™

2022-08-12

ALCON LABORATORIES6201 South Freeway R3-48fort Worth, TX 76134 PMA NumberP950018 Supplement NumberS021 Date Received07/18/2022 Decision Date08/12/2022 Product Code LWL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Cha...

Lotrafilcon A and B Soft Contact Lenses

2022-07-06

Alcon Laboratories, Inc.6201 South Freewayfort Worth, TX 76134-2099 PMA NumberP010019 Supplement NumberS083 Date Received06/09/2022 Decision Date07/06/2022 Product Code LPM  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Proces...

AcrySof Posterior Chamber Intraocular Lens and Delivery Systems

2022-05-18

ALCON LABORATORIES, INC.6201 South Freeway Dr.fort Worth, TX 76134 PMA NumberP930014 Supplement NumberS143 Date Received04/22/2022 Decision Date05/18/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process...

AcrySof Posterior Chamber Intraocular Lens and Delivery Systems

2022-03-25

ALCON LABORATORIES, INC.6201 South Freeway Dr.fort Worth, TX 76134 PMA NumberP930014 Supplement NumberS142 Date Received03/01/2022 Decision Date03/25/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process...

200 records. Showing 1-40. Next

PMN#

INFINITI

2002-07-02

ALCON LABORATORIES, INC.

87 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next