FDA.reportPublic FDA data

MicroStaar

Primary DI
00840311344796
Brand
MicroStaar
Company
STAAR SURGICAL COMPANY
Model
SFC-45
Catalog number
SFC-45
Device description
Intraocular Lens Insertion Cartridge
Published
2023-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KYBLens, Guide, Intraocular
MSSFolders And Injectors, Intraocular Lens (Iol)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYBLens, Guide, IntraocularOphthalmic1
MSSFolders And Injectors, Intraocular Lens (Iol)Ophthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152357000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152357000MicroSTAAR Injector System CartridgesSTAAR Surgical Company2015-10-30KYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840311344796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840311344796008403113447968403113447960840311344796

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular lens-insertion cartridgeA sterile device designed to contain an intraocular lens (IOL), that may have been pre-folded, to facilitate the insertion (launching) of the folded IOL into the anterior or posterior chamber of the eye through a small incision during ophthalmic surgery. Commonly known as the cartridge, it is typically made of synthetic material and is designed as a funnel-shaped tube that terminates at the distal end in a narrowed opening; the IOL is placed into the wider proximal end. The cartridge is attached to an injector for the insertion, and is removed from the injector once the IOL has been successfully inserted. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
054751110
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840311300143EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.1 (-3.5)VICM5 12.12023-11-30
00840311300150EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.1 (-4.0)VICM5 12.12023-11-30
00840311300167EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.1 (-4.5)VICM5 12.12023-11-30
00840311300174EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.1 (-5.0)VICM5 12.12023-11-30
00840311300181EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.1 (-5.5)VICM5 12.12023-11-30
00840311300228EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.1 (-7.5)VICM5 12.12023-11-30
00840311300235EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.1 (-8.0)VICM5 12.12023-11-30
00840311300297EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.1 (-11.0)VICM5 12.12023-11-30
00840311300303EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.1 (-11.5)VICM5 12.12023-11-30
00840311300518EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.6 (-5.5)VICM5 12.62023-11-30
00840311300525EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.6 (-6.0)VICM5 12.62023-11-30
00840311300532EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.6 (-6.5)VICM5 12.62023-11-30
00840311300587EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.6 (-9.0)VICM5 12.62023-11-30
00840311300594EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.6 (-9.5)VICM5 12.62023-11-30
00840311300600EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.6 (-10.0)VICM5 12.62023-11-30
00840311300624EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.6 (-11.0)VICM5 12.62023-11-30
00840311300631EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.6 (-11.5)VICM5 12.62023-11-30
00840311300648EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.6 (-12.0)VICM5 12.62023-11-30
00840311300655EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.6 (-12.5)VICM5 12.62023-11-30
00840311300662EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.6 (-13.0)VICM5 12.62023-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630055214935VISCOJECT 1.8 Injector SetMedicel AGKYB2026-04-28
07630055213853VISCOJECT 2.2 Injector SetMedicel AGKYB2026-04-24
10757770602497EyeGility™ InserterBausch & Lomb IncorporatedMSS2026-04-05
10757770618115EyeGility™ InserterBausch & Lomb IncorporatedMSS2026-04-05
10814899027454pioli™ IOL Delivery SystemAST PRODUCTS, INC.MSS2026-04-01
07630055212023ACCUJECT 2.2-1P INJECTOR SETMedicel AGMSS2025-12-09
07630055214584ACCUJECT injector Set 2.1-1PMedicel AGMSS2025-09-30
00194613086435MSI Precision Specialty InstrumentsMed Saver, Inc.KYB2025-08-01
00194613123147MSI Precision Specialty InstrumentsMed Saver, Inc.KYB2025-03-21
10818806021016RxSight Insertion DeviceRXSIGHT, INC.MSS2024-11-12
00818806021019RxSight Insertion DeviceRXSIGHT, INC.MSS2024-11-12
00844369016858I9011SLenstec Barbados IncMSS2024-05-06
00844369016865I9012Lenstec Barbados IncMSS2024-05-06
00844369016872I9012FSLenstec Barbados IncMSS2024-05-06
00844369018944LC16Lenstec Barbados IncMSS2024-05-06
00844369018968LC24Lenstec Barbados IncMSS2024-05-06
00844369018975CART45SLenstec Barbados IncMSS2024-05-06
00844369018982CARTMLenstec Barbados IncMSS2024-05-06
00757770520183BLIS-X1Bausch & Lomb IncorporatedMSS2024-03-04
00757770523337BLIS-X0Bausch & Lomb IncorporatedMSS2024-03-04
00757770488964Cystalsert Delivery SystemBausch & Lomb IncorporatedMSS2024-01-18
00757770529032Sofport Easy-Load Lens Delivery System EZ-24Bausch & Lomb IncorporatedMSS2024-01-18
07630055214850Accuject REFRA 2.9 InjectorMedicel AGMSS2023-12-08
07630055211934VISCOJECT 2.2 INJECTOR-SETMedicel AGMSS2023-12-01
07630055211941VISCOJECT 1.8 Injector setMedicel AGMSS2023-12-01
20840311300017MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
20840311300024MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
00840311344802MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
10840311300010MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15
10840311300027MicroStaarSTAAR SURGICAL COMPANYMSS2023-06-15