Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003398873

FEI Number

3003398873

Entity Name

ALCON GRIESHABER AG

City/State/Country

SCHAFFHAUSEN, CH

Establishment Address

WINKELRIEDSTRASSE 52, SCHAFFHAUSEN 8203, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Alcon Laboratories, Inc. (Owner Number: 1610287)

Owner / Operator Contact Address

6201 South Freeway, Fort Worth, TX 76134, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	1977-12-30
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	1994-02-03
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2011-12-14
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	1977-12-30
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2015-11-06
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2015-11-06
HOC	Clip, Iris Retractor	Ophthalmic	Class 1	886.4350	2017-09-27
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	1994-02-03
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2002-04-15
HJI	Lens, Fundus, Hruby, Diagnostic	Ophthalmic	Class 1	886.1395	2017-09-27
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2007-12-13
MLZ	Vitrectomy, Instrument Cutter	Ophthalmic	Class 2	886.4150	2007-12-13
HQR	Apparatus, Cautery, Radiofrequency, Ac-Powered	Ophthalmic	Class 2	886.4100	2007-12-13
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	Class 1	886.4350	2009-04-16

Official Correspondent

No official correspondent registered.

US Agent Details

Dale Schaper Business: ALCON LABORATORIES, INC. Email: dale.schaper@alcon.com Phone: (817) 5686421

Related Public Records

Same Entity

Alcon Laboratories, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013497605	Alcon Research, LLC	Sinking Spring, PA, US
3003701944	OPTONOL, LTD	NEVE ILAN Central, IL
3016232028	LUMITHERA, INC.	Fort Worth, TX, US
3006186389	CIBA VISION JOHOR SDN.BHD.,	GELANG PATAH, JOHOR DARUL TAKZIM, MY
3016075957	IVANTIS, INC.	Irvine, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K091915	Lenstec, Inc.	FLUID ISOLATION DEVICE	2009-10-27
K830812	Alphamedix, Inc.	ALPHAMEDIX I/A HAND-PIECE, 500-001	1983-06-08
K133115	Abbott Medical Optics, Inc.	COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK	2014-02-27
K121721	Abbott Medical Optics, Inc.	LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)	2012-10-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-1670-2013	Abbott Medical Optics, Inc.	2	Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Z-0099-2024	Alcon Research, LLC	2	Constellation Vision System, REF: 8065751150
Z-0305-2026	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 8065751577 CHANDELIER,25GA,W/RFID Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003398873. Last updated year: 2026. Please use registration number 3003398873 when referencing this establishment in official correspondence.