FDA.reportPublic FDA data

REFORM

Primary DI
00380652257053
Brand
REFORM
Company
Alcon Laboratories, Inc.
Model
8065225705
Device description
REFORM CAPS T RING 14.5/12MM The ALCON ReFORM Capsular Tension Ring is a sterile, non-optical ocular implant, manufactured from a single piece of PMMA(POlymethylmethacrylate).
Published
2014-09-24
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
MRJRing, Endocapsular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRJRing, EndocapsularUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380652257053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380652257053003806522570533806522570530380652257053

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
Device Size Text, specify0
Outer Diameter14.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)862-5266web.masterus@alcon.com

Regulatory Flags#

DUNS number
008018525
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380658454418Clareon VivityCNWET4CNWET4-0602026-09-04
00380658454425Clareon VivityCNWET4CNWET4-0652026-09-04
00380658454432Clareon VivityCNWET4CNWET4-0702026-09-04
00380658454449Clareon VivityCNWET4CNWET4-0752026-09-04
00380658454456Clareon VivityCNWET4CNWET4-0802026-09-04
00380658454463Clareon VivityCNWET4CNWET4-0852026-09-04
00380658454470Clareon VivityCNWET4CNWET4-0902026-09-04
00380658454487Clareon VivityCNWET4CNWET4-0952026-09-04
00380658454494Clareon VivityCNWET4CNWET4-1002026-09-04
00380658454500Clareon VivityCNWET4CNWET4-1052026-09-04
00380658454517Clareon VivityCNWET4CNWET4-1102026-09-04
00380658454524Clareon VivityCNWET4CNWET4-1152026-09-04
00380658454531Clareon VivityCNWET4CNWET4-1202026-09-04
00380658454548Clareon VivityCNWET4CNWET4-1252026-09-04
00380658454555Clareon VivityCNWET4CNWET4-1302026-09-04
00380658454562Clareon VivityCNWET4CNWET4-1352026-09-04
00380658454579Clareon VivityCNWET4CNWET4-1402026-09-04
00380658454586Clareon VivityCNWET4CNWET4-1452026-09-04
00380658454593Clareon VivityCNWET4CNWET4-1502026-09-04
00380658454609Clareon VivityCNWET4CNWET4-1552026-09-04

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
08717819039375StabilEyesOphtec B.V.MRJ2015-06-24
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