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

GUDID 00841542110341

Diopter: -4.0; Cylinder 1.0; 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 ID00841542110341
NIH Device Record Key9cb4f7ed-b978-4c21-a4b3-5047e1d42e36
Commercial Distribution StatusIn Commercial Distribution
Brand NameVisian Toric ICL (Implantable Collamer Lens for Myopia)
Version Model NumberTMICL 13.7 (-4.0/1.0)
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
GS100841542110341 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-19
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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