Visian Toric ICL (Implantable Collamer Lens for Myopia) TMICL13.7

GUDID 00841542112291

Diopter: -17.5; Cylinder 4.0; Overall Diameter (Length): 13.7

STAAR SURGICAL COMPANY

Posterior-chamber intraocular lens, phakic Posterior-chamber intraocular lens, phakic Posterior-chamber intraocular lens, phakic Posterior-chamber intraocular lens, phakic Posterior-chamber intraocular lens, phakic Posterior-chamber intraocular lens, phakic Posterior-chamber intraocular lens, phakic Posterior-chamber intraocular lens, phakic Posterior-chamber intraocular lens, phakic Posterior-chamber intraocular lens, phakic Posterior-chamber intraocular lens, phakic Posterior-chamber intraocular lens, phakic Posterior-chamber intraocular lens, phakic
Primary Device ID00841542112291
NIH Device Record Keydbaf9ea3-0aa4-4362-bb7b-73e7246c35bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameVisian Toric ICL (Implantable Collamer Lens for Myopia)
Version Model NumberTMICL 13.7 (-17.5/4.0)
Catalog NumberTMICL13.7
Company DUNS054751110
Company NameSTAAR SURGICAL COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841542112291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QCBPhakic Toric Intraocular Lens

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-04
Device Publish Date2018-10-17

On-Brand Devices [Visian Toric ICL (Implantable Collamer Lens for Myopia)]

00084154211291Diopter: -17.5; Cylinder 4.0; Overall Diameter (Length): 13.7
00841542112369Diopter: -18.0; Cylinder 4.0; Overall Diameter (Length): 13.7
00841542112284Diopter: -17.5; Cylinder 3.5; Overall Diameter (Length): 13.7
00841542112277Diopter: -17.5; Cylinder 3.0; Overall Diameter (Length): 13.7
00841542112222Diopter: -17.0; Cylinder 4.0; Overall Diameter (Length): 13.7
00841542112215Diopter: -17.0; Cylinder 3.5; Overall Diameter (Length): 13.7
00841542112208Diopter: -17.0; Cylinder 3.0; Overall Diameter (Length): 13.7
00841542112192Diopter: -17.0; Cylinder 2.5; Overall Diameter (Length): 13.7
00841542112185Diopter: -17.0; Cylinder 2.0; Overall Diameter (Length): 13.7
00841542112154Diopter: -16.5; Cylinder 4.0; Overall Diameter (Length): 13.7
00841542112147Diopter: -16.5; Cylinder 3.5; Overall Diameter (Length): 13.7
00841542112130Diopter: -16.5; Cylinder 3.0; Overall Diameter (Length): 13.7
00841542112123Diopter: -16.5; Cylinder 2.5; Overall Diameter (Length): 13.7
00841542112116Diopter: -16.5; Cylinder 2.0; Overall Diameter (Length): 13.7
00841542112109Diopter: -16.5; Cylinder 1.5; Overall Diameter (Length): 13.7
00841542112093Diopter: -16.5; Cylinder 1.0; Overall Diameter (Length): 13.7
00841542112086Diopter: -16.0; Cylinder 4.0; Overall Diameter (Length): 13.7
00841542112079Diopter: -16.0; Cylinder 3.5; Overall Diameter (Length): 13.7
00841542112062Diopter: -16.0; Cylinder 3.0; Overall Diameter (Length): 13.7
00841542112055Diopter: -16.0; Cylinder 2.5; Overall Diameter (Length): 13.7
00841542112048Diopter: -16.0; Cylinder 2.0; Overall Diameter (Length): 13.7
00841542112031Diopter: -16.0; Cylinder 1.5; Overall Diameter (Length): 13.7
00841542112024Diopter: -16.0; Cylinder 1.0; Overall Diameter (Length): 13.7
00841542112017Diopter: -15.5; Cylinder 4.0; Overall Diameter (Length): 13.7
00841542112000Diopter: -15.5; Cylinder 3.5; Overall Diameter (Length): 13.7
00841542111997Diopter: -15.5; Cylinder 3.0; Overall Diameter (Length): 13.7
00841542111980Diopter: -15.5; Cylinder 2.5; Overall Diameter (Length): 13.7
00841542111973Diopter: -15.5; Cylinder 2.0; Overall Diameter (Length): 13.7
00841542111966Diopter: -15.5; Cylinder 1.5; Overall Diameter (Length): 13.7
00841542111959Diopter: -15.5; Cylinder 1.0; Overall Diameter (Length): 13.7
00841542111942Diopter: -15.0; Cylinder 4.0; Overall Diameter (Length): 13.7
00841542111935Diopter: -15.0; Cylinder 3.5; Overall Diameter (Length): 13.7
00841542111928Diopter: -15.0; Cylinder 3.0; Overall Diameter (Length): 13.7
00841542111911Diopter: -15.0; Cylinder 2.5; Overall Diameter (Length): 13.7
00841542111904Diopter: -15.0; Cylinder 2.0; Overall Diameter (Length): 13.7
00841542111898Diopter: -15.0; Cylinder 1.5; Overall Diameter (Length): 13.7
00841542111881Diopter: -15.0; Cylinder 1.0; Overall Diameter (Length): 13.7
00841542111874Diopter: -14.5; Cylinder 4.0; Overall Diameter (Length): 13.7
00841542111867Diopter: -14.5; Cylinder 3.5; Overall Diameter (Length): 13.7
00841542111850Diopter: -14.5; Cylinder 3.0; Overall Diameter (Length): 13.7
00841542111843Diopter: -14.5; Cylinder 2.5; Overall Diameter (Length): 13.7
00841542111836Diopter: -14.5; Cylinder 2.0; Overall Diameter (Length): 13.7
00841542111829Diopter: -14.5; Cylinder 1.5; Overall Diameter (Length): 13.7
00841542111812Diopter: -14.5; Cylinder 1.0; Overall Diameter (Length): 13.7
00841542111805Diopter: -14.0; Cylinder 4.0; Overall Diameter (Length): 13.7
00841542111799Diopter: -14.0; Cylinder 3.5; Overall Diameter (Length): 13.7
00841542111782Diopter: -14.0; Cylinder 3.0; Overall Diameter (Length): 13.7
00841542111775Diopter: -14.0; Cylinder 2.5; Overall Diameter (Length): 13.7
00841542111768Diopter: -14.0; Cylinder 2.0; Overall Diameter (Length): 13.7
00841542111751Diopter: -14.0; Cylinder 1.5; Overall Diameter (Length): 13.7

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