Visian ICL (Implantable Collamer Lens)

GUDID 00841542102940

Diopter: -6.0; Overall Diameter (Length): 12.6 mm

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 ID00841542102940
NIH Device Record Keyeb5d1bd4-b7d6-4434-9417-db8ab62d85d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameVisian ICL (Implantable Collamer Lens)
Version Model NumberMICL 12.6
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
GS100841542102940 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MTALens, Intraocular, Phakic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-20

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

00841542103688Diopter: -16.0; Overall Diameter (Length): 13.7 mm
00841542103671Diopter: -15.5; Overall Diameter (Length): 13.7 mm
00841542103664Diopter: -15.0; Overall Diameter (Length): 13.7 mm
00841542103657Diopter: -14.5; Overall Diameter (Length): 13.7 mm
00841542103640Diopter: -14.0; Overall Diameter (Length): 13.7 mm
00841542103633Diopter: -13.5; Overall Diameter (Length): 13.7 mm
00841542103626Diopter: -13.0; Overall Diameter (Length): 13.7 mm
00841542103619Diopter: -12.5; Overall Diameter (Length): 13.7 mm
00841542103602Diopter: -12.0; Overall Diameter (Length): 13.7 mm
00841542103596Diopter: -11.5; Overall Diameter (Length): 13.7 mm
00841542103589Diopter: -11.0; Overall Diameter (Length): 13.7 mm
00841542103572Diopter: -10.5; Overall Diameter (Length): 13.7 mm
00841542103565Diopter: -10.0; Overall Diameter (Length): 13.7 mm
00841542103558Diopter: -9.5; Overall Diameter (Length): 13.7 mm
00841542103541Diopter: -9.0; Overall Diameter (Length): 13.7 mm
00841542103534Diopter: -8.5; Overall Diameter (Length): 13.7 mm
00841542103527Diopter: -8.0; Overall Diameter (Length): 13.7 mm
00841542103510Diopter: -7.5; Overall Diameter (Length): 13.7 mm
00841542103503Diopter: -7.0; Overall Diameter (Length): 13.7 mm
00841542103497Diopter: -6.5; Overall Diameter (Length): 13.7 mm
00841542103480Diopter: -6.0; Overall Diameter (Length): 13.7 mm
00841542103473Diopter: -5.5; Overall Diameter (Length): 13.7 mm
00841542103466Diopter: -5.0; Overall Diameter (Length): 13.7 mm
00841542103459Diopter: -4.5; Overall Diameter (Length): 13.7 mm
00841542103442Diopter: -4.0; Overall Diameter (Length): 13.7 mm
00841542103435Diopter: -3.5; Overall Diameter (Length): 13.7 mm
00841542103428Diopter: -3.0; Overall Diameter (Length): 13.7 mm
00841542103411Diopter: -16.0; Overall Diameter (Length): 13.2 mm
00841542103404Diopter: -15.5; Overall Diameter (Length): 13.2 mm
00841542103398Diopter: -15.0; Overall Diameter (Length): 13.2 mm
00841542103381Diopter: -14.5; Overall Diameter (Length): 13.2 mm
00841542103374Diopter: -14.0; Overall Diameter (Length): 13.2 mm
00841542103367Diopter: -13.5; Overall Diameter (Length): 13.2 mm
00841542103350Diopter: -13.0; Overall Diameter (Length): 13.2 mm
00841542103343Diopter: -12.5; Overall Diameter (Length): 13.2 mm
00841542103336Diopter: -12.0; Overall Diameter (Length): 13.2 mm
00841542103329Diopter: -11.5; Overall Diameter (Length): 13.2 mm
00841542103312Diopter: -11.0; Overall Diameter (Length): 13.2 mm
00841542103305Diopter: -10.5; Overall Diameter (Length): 13.2 mm
00841542103299Diopter: -10.0; Overall Diameter (Length): 13.2 mm
00841542103282Diopter: -9.5; Overall Diameter (Length): 13.2 mm
00841542103275Diopter: -9.0; Overall Diameter (Length): 13.2 mm
00841542103268Diopter: -8.5; Overall Diameter (Length): 13.2 mm
00841542103251Diopter: -8.0; Overall Diameter (Length): 13.2 mm
00841542103244Diopter: -7.5; Overall Diameter (Length): 13.2 mm
00841542103237Diopter: -7.0; Overall Diameter (Length): 13.2 mm
00841542103220Diopter: -6.5; Overall Diameter (Length): 13.2 mm
00841542103213Diopter: -6.0; Overall Diameter (Length): 13.2 mm
00841542103206Diopter: -5.5; Overall Diameter (Length): 13.2 mm
00841542103190Diopter: -5.0; Overall Diameter (Length): 13.2 mm

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