FDA.reportPublic FDA data

Artisan

Primary DI
08717819060140
Brand
Artisan
Company
Ophtec B.V.
Model
204US1W
Catalog number
204US1W12N
Device description
Artisan Myopia 6/8.5mm -6.0D
Published
2015-08-25
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

Contact Domains#

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
P030028001
P030028002
P030028003
P030028004
P030028005
P030028006
P030028008
P030028009
P030028012

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030028001ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL)Ophtec BV2004-09-10MTA
P030028002ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL)Ophtec BV2004-09-10MTA
P030028003ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL)Ophtec BV2004-09-10MTA
P030028004ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL)Ophtec BV2004-09-10MTA
P030028005ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL)Ophtec BV2004-09-10MTA
P030028006ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL)Ophtec BV2004-09-10MTA
P030028008ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL)Ophtec BV2004-09-10MTA
P030028009ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL)Ophtec BV2004-09-10MTA
P030028012ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL)Ophtec BV2004-09-10MTA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717819060140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717819060140087178190601408717819060140

GMDN Terms#

Term, Definition table
TermDefinition
Anterior-chamber intraocular lens, phakicAn optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the region of the eye posterior of the cornea and anterior of the iris (anterior chamber) to provide refractive correction of vision without removal of the natural lens (crystalline lens). The device is typically made of a synthetic polymer; disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+31505251944info@ophtec.com

Regulatory Flags#

DUNS number
405048120
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717819060126Artisan204US1W204US1W10N2015-08-25
08717819060133Artisan204US1W204US1W11N2015-08-25
08717819060157Artisan204US1W204US1W13N2015-08-25
08717819060164Artisan204US1W204US1W14N2015-08-25
08717819060171Artisan204US1W204US1W15N2015-08-25
08717819060188Artisan204US1W204US1W16N2015-08-25
08717819060195Artisan204US1W204US1W17N2015-08-25
08717819060201Artisan204US1W204US1W18N2015-08-25
08717819060218Artisan204US1W204US1W19N2015-08-25
08717819060225Artisan204US1W204US1W20N2015-08-25
08717819060232Artisan204US1W204US1W21N2015-08-25
08717819060249Artisan204US1W204US1W22N2015-08-25
08717819060256Artisan204US1W204US1W23N2015-08-25
08717819060263Artisan204US1W204US1W24N2015-08-25
08717819060270Artisan204US1W204US1W25N2015-08-25
08717819060287Artisan204US1W204US1W26N2015-08-25
08717819060294Artisan204US1W204US1W27N2015-08-25
08717819060300Artisan204US1W204US1W28N2015-08-25
08717819060317Artisan204US1W204US1W29N2015-08-25
08717819060324Artisan204US1W204US1W30N2015-08-25

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
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