FDA.reportPublic FDA data

StabilEyes

Primary DI
08717819039375
Brand
StabilEyes
Company
Ophtec B.V.
Model
STBL12US
Catalog number
STBL12US
Device description
Capsular Tension Ring 12.0 mm.
Published
2015-06-24
Public version status
Update
Distribution status
Not 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
MRJRing, Endocapsular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRJRing, EndocapsularUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030023001
P030023002
P030023007

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030023001OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13USOphtec BV2004-04-27MRJ
P030023002OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13USOphtec BV2004-04-27MRJ
P030023007OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13USOphtec BV2004-04-27MRJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717819039375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717819039375087178190393758717819039375

GMDN Terms#

Term, Definition table
TermDefinition
Capsular tension ringA sterile, open-ended, non-optical circular band intended to be used to enhance the mechanical stability of a subluxated crystalline lens capsule in the presence of weak or absent supporting zonules. The device, commonly known as a capsular tension ring (CTR) or an endocapsular ring, is permanently implanted in the crystalline lens capsular bag during intraocular lens (IOL) surgery (e.g., cataract extraction) where it produces tension to distend the bag. It is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)]. Disposable devices associated with implantation (e.g., inserter) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter12Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature50 Degrees Fahrenheit80 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(877)266-4543SAN-SURGICAL-ORDERS@AMO.ABBOTT.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
08717819060140Artisan204US1W204US1W12N2015-08-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048509620004EYEJET® CTR Type 20C RightMorcher GmbHMRJ2023-09-14
08717819029789Capsular Tension RingOphtec B.V.MRJ2018-09-24
08717819090222Capsular Tension RingOphtec B.V.MRJ2018-09-24
08717819049176Artisan/ArtiflexOphtec B.V.MRJ2018-09-24
08717819070279RingJectOphtec B.V.MRJ2016-10-07
08717819070286RingJectOphtec B.V.MRJ2016-10-07
08717819039399StabilEyesOphtec B.V.MRJ2015-06-24
04048509392086EYEJET® CTRMorcher GmbHMRJ2014-11-18
04048509392093EYEJET® CTRMorcher GmbHMRJ2014-11-18
04048509392109EYEJET® CTRMorcher GmbHMRJ2014-11-18
04048509391881NAMorcher GmbHMRJ2014-10-31
04048509391898NAMorcher GmbHMRJ2014-10-31
04048509391904NAMorcher GmbHMRJ2014-10-31
04048509391911NAMorcher GmbHMRJ2014-10-31
04048509391928NAMorcher GmbHMRJ2014-10-31
04048509391935NAMorcher GmbHMRJ2014-10-31
04048509391942NAMorcher GmbHMRJ2014-10-31
04048509391959NAMorcher GmbHMRJ2014-10-31
04048509391966NAMorcher GmbHMRJ2014-10-31
04048509391973NAMorcher GmbHMRJ2014-10-31
04048509391980NAMorcher GmbHMRJ2014-10-31
04048509391997EYEJET® CTRMorcher GmbHMRJ2014-10-31
04048509392000EYEJET® CTRMorcher GmbHMRJ2014-10-31
04048509392017EYEJET® CTRMorcher GmbHMRJ2014-10-31
04048509392024EYEJET® CTRMorcher GmbHMRJ2014-10-31
04048509392031EYEJET® CTRMorcher GmbHMRJ2014-10-31
04048509392048EYEJET® CTRMorcher GmbHMRJ2014-10-31
04048509392055EYEJET® CTRMorcher GmbHMRJ2014-10-31
04048509392062EYEJET® CTRMorcher GmbHMRJ2014-10-31
04048509392079EYEJET® CTRMorcher GmbHMRJ2014-10-31