Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2023826

FEI Number

2023826

Entity Name

STAAR SURGICAL COMPANY

City/State/Country

MONROVIA, CA, US

Establishment Address

1911 WALKER AVE., MONROVIA, CA 91016, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,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

K073586

PMA Number

N/A

All Registered Proprietary Names

MicroSTAAR Injector System (TM/PM) MicroSTAAR Injector System (TD/PD) 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 Collamer UVA PC Introcular Lens MICROSTAAR STAAR SURGICAL SILICONE NON-UV ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS MICROSTAAR MICROSTAAR MicroSTAAR Injector System (TF/PF) MICROSTAAR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYB	Lens, Guide, Intraocular	Ophthalmic	Class 1	886.4300	2007-11-12
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
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2007-11-12
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2016-12-19
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2018-09-26
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
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2017-11-20
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	2008-10-28

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
3014173684	STAAR Surgical Company	Tustin, 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-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)
Z-0929-2013	Abbott Medical Optics Inc (AMO)	3	AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2023826. Last updated year: 2026. Please use registration number 2023826 when referencing this establishment in official correspondence.