Data / Medical devices / Switzerland / Alcon Grieshaber AG

Alcon Grieshaber AG: FDA-registered device maker in Schaffhausen, Switzerland, 3 510(k) clearances

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

Alcon Grieshaber AG is registered with the FDA (registration 3003398873) in Schaffhausen, Switzerland. It lists 13 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 22, 2014. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003398873
Address: Winkelriedstrasse 52, Schaffhausen, Switzerland, 8203
Owner or operator: Alcon Laboratories, Inc. (1610287)
Roles: Manufacturer
First device listed: December 30, 1977
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Cautery, Radiofrequency, Ac-Powered	HQR	2	Manufacturer	accessdata.fda.gov
Cannula, Ophthalmic	HMX	1	Manufacturer	accessdata.fda.gov
Cannula, Trocar, Ophthalmic	NGY	1	Manufacturer	accessdata.fda.gov
Clip, Iris Retractor	HOC	1	Manufacturer	accessdata.fda.gov
Forceps, Ophthalmic	HNR	1	Manufacturer	accessdata.fda.gov
Hook, Ophthalmic	HNQ	1	Manufacturer	accessdata.fda.gov
Instrument, Vitreous Aspiration And Cutting, Ac-Powered	HQE	2	Manufacturer	accessdata.fda.gov
Knife, Ophthalmic	HNN	1	Manufacturer	accessdata.fda.gov
Lens, Fundus, Hruby, Diagnostic	HJI	1	Manufacturer	accessdata.fda.gov
Scissors, Ophthalmic	HNF	1	Manufacturer	accessdata.fda.gov
Spatula, Ophthalmic	HND	1	Manufacturer	accessdata.fda.gov
Unit, Phacofragmentation	HQC	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
August 22, 2014	K141065	CONSTELLATION VISION SYSTEM	HQE	Substantially Equivalent	Alcon Research, Ltd.	accessdata.fda.gov
November 12, 2010	K101285	CONSTELLATION VISION SYSTEM	HQC	Substantially Equivalent	Alcon Manufacturing, Ltd.	accessdata.fda.gov
July 2, 2002	K021566	INFINITI	HQC	Substantially Equivalent	Alcon Laboratories, 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
April 17, 2013	65006	Class II	Terminated	The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.	Alcon is conducting a Medical Device Removal for the Constellation Pneumatic Handpiece, DSP, product number 725.01. This action is being taken because the forceps or scissors tips (sold separately) may dislodge from the hand piece, if not attached by the user according to the Directions for Use.	accessdata.fda.gov

Compare with other makers

Updated August 22, 2014. 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.