Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614429

FEI Number

3002808259

Entity Name

STAAR SURGICAL AG

City/State/Country

NIDAU Bern, CH

Establishment Address

104 HAUPTSTRASSE, NIDAU Bern CH-2560, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

STAAR SURGICAL Company (Owner Number: 2023826)

Owner / Operator Contact Address

1911 WALKER AVE., --, Monrovia, CA 91016, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P030016

All Registered Proprietary Names

EVO+ VISIAN Implantable Collamer Lens EVO+ VISIAN Toric Implantable Collamer Lens EVO VISIAN Toric Implantable Collamer Lens EVO VISIAN Implantable Collamer Lens Implantable Collamer Lens

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QCB	Phakic Toric Intraocular Lens	Ophthalmic	Class 3	886.3600	2007-11-12
MTA	Lens, Intraocular, Phakic	Unknown	Class 3	N/A	2007-11-12

Official Correspondent

Magda Michna

US Agent Details

Magda Michna Email: mmichna@staar.com Phone: (626) 3037902

Related Public Records

Same Entity

STAAR SURGICAL Company

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014173684	STAAR Surgical Company	Tustin, CA, US
2023826	STAAR SURGICAL COMPANY	MONROVIA, CA, US

Similar Registrations

Registration Number	Establishment Name	Location
3014173684	STAAR Surgical Company	Tustin, CA, US
2023826	STAAR SURGICAL COMPANY	MONROVIA, CA, US
8040449	OPHTEC BV	GRONINGEN, NL
3005941719	Sterigenics Belgium Petit Rechain S.A.	Verviers Liege, BE
3031365458	WOMED SAS	Montpellier Herault, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614429. Last updated year: 2026. Please use registration number 9614429 when referencing this establishment in official correspondence.