Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014173684

FEI Number

3014173684

Entity Name

STAAR Surgical Company

City/State/Country

Tustin, CA, US

Establishment Address

15102 Red Hill Avenue, Tustin, CA 92780, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K090161

PMA Number

N/A

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 MICROSTAAR MICROSTAAR Elastimide UVA PC Toric IOL Elastimide UVA PC Intraocular Lens Elastic UVA PC Intraocular Lens MicroSTAAR Injector System (TM/PM) MicroSTAAR Injector System (TD/PD) MICROSTAAR MicroSTAAR Injector System (TF/PF) Epiphany

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
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2008-10-28
KYB	Lens, Guide, Intraocular	Ophthalmic	Class 1	886.4300	2016-12-19
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2016-12-19
MJP	Lens, Intraocular, Toric Optics	Ophthalmic	Class 3	886.3600	1992-10-22
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	1992-10-22
KYB	Lens, Guide, Intraocular	Ophthalmic	Class 1	886.4300	2007-11-12
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2016-12-19
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2006-02-16
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2009-06-22

Official Correspondent

Magda Michna

US Agent Details

No US Agent registered (Local establishment).

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
9614429	STAAR SURGICAL AG	NIDAU Bern, CH
2023826	STAAR SURGICAL COMPANY	MONROVIA, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K823222	American Medical Optics	INTRAOCULAR LENS GUIDE	1982-12-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0835-2025	Alcon Research LLC	1	Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch III D delivery cartridge Lens Guide, Intraocular Component: N/A
Z-0028-2022	Johnson & Johnson Surgical Vision Inc	3	TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile, disposable insertion system for delivering the IOL into the eye during cataract surgery.
Z-0275-2012	Abbott Medical Optics Inc (AMO)	3	Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.
Z-0276-2012	Abbott Medical Optics Inc (AMO)	3	Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.
Z-0605-2010	Abbott Medical Optics Inc (AMO)	3	AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)

Similar Registrations

Registration Number	Establishment Name	Location
2023826	STAAR SURGICAL COMPANY	MONROVIA, CA, US
9614429	STAAR SURGICAL AG	NIDAU Bern, CH
8040449	OPHTEC BV	GRONINGEN, NL
3005941719	Sterigenics Belgium Petit Rechain S.A.	Verviers Liege, BE
2523835	Alcon Research, LLC	Sinking Spring, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014173684. Last updated year: 2026. Please use registration number 3014173684 when referencing this establishment in official correspondence.