FDA.reportPublic FDA data

EVO/EVO+VISIAN Implantable Collamer Lens

Primary DI
00840311300143
Brand
EVO/EVO+VISIAN Implantable Collamer Lens
Company
STAAR SURGICAL COMPANY
Model
VICM5 12.1 (-3.5)
Catalog number
VICM5 12.1
Device description
VICM5 - Diopter: -3.5; Overall Diameter (Length): 12.1
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
00840311300143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840311300143008403113001438403113001430840311300143

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). Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

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
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
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
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
00840311300655EVO/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