FDA.reportPublic FDA data

Visian Toric ICL (Implantable Collamer Lens for Myopia)

Primary DI
00841542104272
Brand
Visian Toric ICL (Implantable Collamer Lens for Myopia)
Company
STAAR SURGICAL COMPANY
Model
TMICL 12.1 (-7.0/2.0)
Catalog number
TMICL12.1
Device description
Diopter: -7.0; Cylinder 2.0; Overall Diameter (Length): 12.1
Published
2018-10-17
Public version status
Update
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
QCBPhakic Toric Intraocular Lens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QCBPhakic Toric Intraocular LensOphthalmic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841542104272PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841542104272008415421042728415421042720841542104272

GMDN Terms#

Term, Definition table
TermDefinition
Posterior-chamber intraocular lens, phakicAn optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to provide refractive correction of vision, typically in the treatment of myopia or hyperopia, without removal of the natural lens (crystalline lens). The device is typically made of a synthetic polymer; it is also referred to as an implantable contact lens (ICL).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
054751110
Device count
1
Serial number
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
00840311304349EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311304363EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311304479EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311304523EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311304547EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311304677EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311304684EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311304745EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311304776EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311304806EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311304905EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311304912EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311304936EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311304998EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311305018EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311305063EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311305070EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311305094EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311305100EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311305209EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311305223EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311305254EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311305278EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311305285EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311305339EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311305346EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311305353EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311305360EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311305483EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30
00840311305568EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYQCB2023-11-30