FDA.reportPublic FDA data

Visian Toric ICL (Implantable Collamer Lens for Myopia)

Primary DI
00841542105101
Brand
Visian Toric ICL (Implantable Collamer Lens for Myopia)
Company
STAAR SURGICAL COMPANY
Model
TMICL 12.1 (-13.0/1.5)
Catalog number
TMICL12.1
Device description
Diopter: -13.0; Cylinder 1.5; Overall Diameter (Length): 12.1
Published
2018-10-17
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
QCBPhakic Toric Intraocular Lens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QCBPhakic Toric Intraocular LensOphthalmic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030016001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030016001VISIAN ICL (IMPLANTABLE COLLAMER LENS)STAAR Surgical Company2005-12-22MTA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841542105101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841542105101008415421051018415421051010841542105101

GMDN Terms#

Term, Definition table
TermDefinition
Umbilical cord clamp/cutterA sterile, hand-held manual surgical instrument designed with a clamping and cutting mechanism to simultaneously clamp and sever the umbilical cord immediately after birth. It may be used on the maternal side of the umbilical cord and on the infant side, typically where the clamp remains until the cord stub falls off. It is typically made of plastic materials [e.g., polycarbonate (PC)]. This is a single-use device.

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