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Staar Surgical Company: FDA-registered device maker in Monrovia, CA, United States, 8 510(k) clearances and 4 PMA approvals

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

Staar Surgical Company is registered with the FDA (registration 2023826) in Monrovia, CA, United States. It lists 6 device types. The FDA files 8 510(k) clearances and 4 PMA approvals under its listings, the newest dated September 6, 2017. 11 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2023826
Address: 1911 Walker Ave., Monrovia, CA, United States, 91016
Owner or operator: STAAR SURGICAL Company (2023826)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: October 22, 1992
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, Elastic UVA PC Intraocular Lens, Elastimide UVA PC Intraocular Lens, Elastimide UVA PC Toric IOL and more

Devices it lists

Device	Product code	Class	Role	Source
Folders And Injectors, Intraocular Lens (Iol)	MSS	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Intraocular Lens	HQL	3	Complaint file establishment, Manufacturer	accessdata.fda.gov
Lens, Guide, Intraocular	KYB	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Lens, Intraocular, Phakic	MTA	3	Manufacturer, Specification developer	accessdata.fda.gov
Lens, Intraocular, Toric Optics	MJP	3	Manufacturer	accessdata.fda.gov
Phakic Toric Intraocular Lens	QCB	3	Manufacturer, Specification developer	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
September 6, 2017	K172375	MicroSTAAR Injector System Cartridges	MSS	Substantially Equivalent	STAAR Surgical Company	accessdata.fda.gov
October 30, 2015	K152357	MicroSTAAR Injector System Cartridges	KYB	Substantially Equivalent	STAAR Surgical Company	accessdata.fda.gov
December 22, 2010	K101782	MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE	MSS	Substantially Equivalent	Staar Japan	accessdata.fda.gov
June 9, 2009	K090161	EPIPHANY INJECTION SYSTEM	MSS	Substantially Equivalent	Staar Surgical Co.	accessdata.fda.gov
March 13, 2008	K073586	MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM	MSS	Substantially Equivalent	Staar Surgical Co.	accessdata.fda.gov
September 11, 1998	K980696	FOAM TIP INJECTOR	MSS	Substantially Equivalent	Staar Surgical Co.	accessdata.fda.gov
December 21, 1995	K954600	MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)	KYB	Substantially Equivalent	Staar Surgical Co.	accessdata.fda.gov
September 19, 1994	K940593	DISPOSABLE MICROSTAAR INJECTOR	KYB	Substantially Equivalent	Staar Sugical	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
September 17, 1991	P900048	ELASTIMIDE(TM) SILICONE MODIFIED J-LOOP POST. CHAM		2	August 23, 1993	accessdata.fda.gov
September 16, 1991	P880091	ELASTIC UVA PC IOL.	HQL	29	September 16, 2010	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 29, 2023	93312	Class II	Ongoing	EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.	Their is a potential that intraocular implant devices may not meet specifications.	accessdata.fda.gov
May 2, 2016	74067	Class II	Terminated	STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.	The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).	accessdata.fda.gov
June 10, 2013	65558	Class II	Terminated	nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior chamber and in the cap	STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.	accessdata.fda.gov
May 20, 2011	59028	Not yet classified	Terminated	Brand Name STAAR Surgical Collamer Ultraviolet-Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens Common Names Collamer single piece IOL Collamer plate haptic IOL The Device is intended to correct aphakia	The recall was initiated by Staar Surgical due to an error in the Directions for Use (DFU) for Staar Surgical's Collamer Ultraviolet Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens (Collamer IP IOL), also known as the nanoFLEX IOL. The Device Description erroneously indicates that the lens could be implanted in the ciliary sulcus.	accessdata.fda.gov
July 18, 2005	32798	Not yet classified	Terminated	Staarvisic II Sodium Hyaluronate, 0.8 mL	Sterility may be compromised.	accessdata.fda.gov
March 28, 2005	31653	Not yet classified	Terminated	STAAR Phaco Tubing Kit	Complaints of leaking with question of sterility and risk of infection in eye.	accessdata.fda.gov
June 17, 2004	29384	Not yet classified	Terminated	STAAR Surgical Intra Occular Lens, Collamer.	Mislabeled in part. Label set, patient chart labels, and patient ID card serial number did not match the IOL serial number.	accessdata.fda.gov
April 21, 2004	28896	Not yet classified	Terminated	MicroSTAAR Injector, MSI-PF Packed ten per box.	Cracking of the distal end of the injector occurs during locking of the cartridge into the nose cone of the injector.	accessdata.fda.gov
February 23, 2004	28570	Not yet classified	Terminated	MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF	Injector mold design/manufacture and wear caused material flash to develop preventing assembly of the device prior to use.	accessdata.fda.gov
February 9, 2004	28264	Not yet classified	Terminated	Collamer UV One-Piece IntraOcular Lens. Models 4205BF and 4204BF	Risk of hyperopic refractive changes.	accessdata.fda.gov
January 6, 2004	28070	Not yet classified	Terminated	MicroSTAAR Injector Cartridges Models: SFC-25 (utilized with plate haptic Collamer lens) MTC-60 (utilized with plate haptic Silicone lens)	Increased numbers of lens tears during placement of lens into eye.	accessdata.fda.gov

Compare with other makers

Updated March 4, 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.