FDA.reportPublic FDA data

EVO/EVO+VISIAN Implantable Collamer Lens

Primary DI
00840311300655
Brand
EVO/EVO+VISIAN Implantable Collamer Lens
Company
STAAR SURGICAL COMPANY
Model
VICM5 12.6 (-12.5)
Catalog number
VICM5 12.6
Device description
VICM5 - Diopter: -12.5; Overall Diameter (Length): 12.6
Published
2023-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MTALens, Intraocular, Phakic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTALens, Intraocular, PhakicUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030016035

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030016035VISIAN ICL (IMPLANTABLE COLLAMER LENS)STAAR Surgical Company2005-12-22MTA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840311300655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840311300655008403113006558403113006550840311300655

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
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
00840311300662EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.6 (-13.0)VICM5 12.62023-11-30
00840311300679EVO/EVO+VISIAN Implantable Collamer LensVICM5 12.6 (-13.5)VICM5 12.62023-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311300143EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300150EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300167EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300174EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300181EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300228EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300235EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300297EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300303EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300518EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300525EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300532EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300587EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300594EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300600EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300624EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300631EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300648EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300662EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300679EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300686EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300808EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300815EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300822EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300846EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300891EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300907EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300914EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311300921EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30
00840311301140EVO/EVO+VISIAN Implantable Collamer LensSTAAR SURGICAL COMPANYMTA2023-11-30