EVO/EVO+VISIAN Implantable Collamer Lens VTICMO 12.1

GUDID 00841542119870

VTICMO - Diopter: -15.5; Cylinder 1.0; Overall Diameter (Length): 12.1

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 Posterior-chamber intraocular lens, phakic Posterior-chamber intraocular lens, phakic Posterior-chamber intraocular lens, phakic
Primary Device ID00841542119870
NIH Device Record Key41993183-1dba-4645-b4ee-93466ad0b8b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVO/EVO+VISIAN Implantable Collamer Lens
Version Model NumberVTICMO 12.1 (-15.5/1.0)
Catalog NumberVTICMO 12.1
Company DUNS054751110
Company NameSTAAR SURGICAL COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
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
GS100841542119870 [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 Date2022-04-22
Device Publish Date2022-04-14

On-Brand Devices [EVO/EVO+VISIAN Implantable Collamer Lens]

00841542122122VICMO - Diopter: -16.0; Overall Diameter (Length): 13.7
00841542122115VICMO - Diopter: -15.5; Overall Diameter (Length): 13.7
00841542122108VICMO - Diopter: -15.0; Overall Diameter (Length): 13.7
00841542122092VICMO - Diopter: -14.5; Overall Diameter (Length): 13.7
00841542122085VICMO - Diopter: -16.0; Overall Diameter (Length): 13.2
00841542122078VICMO - Diopter: -15.5; Overall Diameter (Length): 13.2
00841542122061VICMO - Diopter: -15.0; Overall Diameter (Length): 13.2
00841542122054VICMO - Diopter: -14.5; Overall Diameter (Length): 13.2
00841542122047VICMO - Diopter: -16.0; Overall Diameter (Length): 12.6
00841542122030VICMO - Diopter: -15.5; Overall Diameter (Length): 12.6
00841542122023VICMO - Diopter: -15.0; Overall Diameter (Length): 12.6
00841542122016VICMO - Diopter: -14.5; Overall Diameter (Length): 12.6
00841542122009VICMO - Diopter: -16.0; Overall Diameter (Length): 12.1
00841542121996VICMO - Diopter: -15.5; Overall Diameter (Length): 12.1
00841542121989VICMO - Diopter: -15.0; Overall Diameter (Length): 12.1
00841542121972VICMO - Diopter: -14.5; Overall Diameter (Length): 12.1
00841542121965VTICMO - Diopter: -18.0; Cylinder 4.0; Overall Diameter (Length): 13.7
00841542121897VTICMO - Diopter: -17.5; Cylinder 4.0; Overall Diameter (Length): 13.7
00841542121880VTICMO - Diopter: -17.5; Cylinder 3.5; Overall Diameter (Length): 13.7
00841542121873VTICMO - Diopter: -17.5; Cylinder 3.0; Overall Diameter (Length): 13.7
00841542121828VTICMO - Diopter: -17.0; Cylinder 4.0; Overall Diameter (Length): 13.7
00841542121811VTICMO - Diopter: -17.0; Cylinder 3.5; Overall Diameter (Length): 13.7
00841542121804VTICMO - Diopter: -17.0; Cylinder 3.0; Overall Diameter (Length): 13.7
00841542121798VTICMO - Diopter: -17.0; Cylinder 2.5; Overall Diameter (Length): 13.7
00841542121781VTICMO - Diopter: -17.0; Cylinder 2.0; Overall Diameter (Length): 13.7
00841542121750VTICMO - Diopter: -16.5; Cylinder 4.0; Overall Diameter (Length): 13.7
00841542121743VTICMO - Diopter: -16.5; Cylinder 3.5; Overall Diameter (Length): 13.7
00841542121736VTICMO - Diopter: -16.5; Cylinder 3.0; Overall Diameter (Length): 13.7
00841542121729VTICMO - Diopter: -16.5; Cylinder 2.5; Overall Diameter (Length): 13.7
00841542121712VTICMO - Diopter: -16.5; Cylinder 2.0; Overall Diameter (Length): 13.7
00841542121705VTICMO - Diopter: -16.5; Cylinder 1.5; Overall Diameter (Length): 13.7
00841542121699VTICMO - Diopter: -16.5; Cylinder 1.0; Overall Diameter (Length): 13.7
00841542121682VTICMO - Diopter: -16.0; Cylinder 4.0; Overall Diameter (Length): 13.7
00841542121675VTICMO - Diopter: -16.0; Cylinder 3.5; Overall Diameter (Length): 13.7
00841542121668VTICMO - Diopter: -16.0; Cylinder 3.0; Overall Diameter (Length): 13.7
00841542121651VTICMO - Diopter: -16.0; Cylinder 2.5; Overall Diameter (Length): 13.7
00841542121644VTICMO - Diopter: -16.0; Cylinder 2.0; Overall Diameter (Length): 13.7
00841542121637VTICMO - Diopter: -16.0; Cylinder 1.5; Overall Diameter (Length): 13.7
00841542121620VTICMO - Diopter: -16.0; Cylinder 1.0; Overall Diameter (Length): 13.7
00841542121613VTICMO - Diopter: -15.5; Cylinder 4.0; Overall Diameter (Length): 13.7
00841542121606VTICMO - Diopter: -15.5; Cylinder 3.5; Overall Diameter (Length): 13.7
00841542121590VTICMO - Diopter: -15.5; Cylinder 3.0; Overall Diameter (Length): 13.7
00841542121583VTICMO - Diopter: -15.5; Cylinder 2.5; Overall Diameter (Length): 13.7
00841542121576VTICMO - Diopter: -15.5; Cylinder 2.0; Overall Diameter (Length): 13.7
00841542121569VTICMO - Diopter: -15.5; Cylinder 1.5; Overall Diameter (Length): 13.7
00841542121552VTICMO - Diopter: -15.5; Cylinder 1.0; Overall Diameter (Length): 13.7
00841542121545VTICMO - Diopter: -15.0; Cylinder 4.0; Overall Diameter (Length): 13.7
00841542121538VTICMO - Diopter: -15.0; Cylinder 3.5; Overall Diameter (Length): 13.7
00841542121521VTICMO - Diopter: -15.0; Cylinder 3.0; Overall Diameter (Length): 13.7
00841542121514VTICMO - Diopter: -15.0; Cylinder 2.5; Overall Diameter (Length): 13.7

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