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Staar Surgical AG: FDA-registered device maker in NIDAU Bern, Switzerland, 2 PMA approvals

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

Staar Surgical AG is registered with the FDA (registration 9614429) in NIDAU Bern, Switzerland. It lists 3 device types. The FDA files 2 PMA approvals under its listings, the newest dated December 22, 2005. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9614429
FEI number: 3002808259
Address: 104 Hauptstrasse, NIDAU Bern, Switzerland, CH-2560
Owner or operator: STAAR SURGICAL Company (2023826)
Roles: Manufacturer
First device listed: November 12, 2007
Registered through: 2026
Brand names listed: Collamer UVA PC Introcular Lens, EVO VISIAN Implantable Collamer Lens, EVO VISIAN Toric Implantable Collamer Lens, EVO+ VISIAN Implantable Collamer Lens, EVO+ VISIAN Toric Implantable Collamer Lens, Implantable Collamer Lens

Devices it lists

Device	Product code	Class	Role	Source
Intraocular Lens	HQL	3	Manufacturer	accessdata.fda.gov
Lens, Intraocular, Phakic	MTA	3	Manufacturer	accessdata.fda.gov
Phakic Toric Intraocular Lens	QCB	3	Manufacturer	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
December 22, 2005	P030016	VISIAN ICL (IMPLANTABLE COLLAMER LENS)	MTA	45	March 4, 2026	accessdata.fda.gov
April 2, 2000	P990013	COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS	HQL	38	July 19, 2021	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 20, 2026	99007	Class II	Ongoing	Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual r	Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.	accessdata.fda.gov
January 21, 2026	98397	Class II	Ongoing	EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5	Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, U	accessdata.fda.gov

Compare with other makers

Updated June 18, 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.