EVO/EVO+VISIAN Implantable Collamer Lens VICM5 13.2

GUDID 00841542119412

VICM5 - Diopter: -10.0; Overall Diameter (Length): 13.2

STAAR SURGICAL COMPANY

Posterior-chamber intraocular lens, phakic

• Primary Device ID: 00841542119412
• NIH Device Record Key: c25ef9c8-b76c-4756-b5e2-dba53a9c606b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVO/EVO+VISIAN Implantable Collamer Lens
• Version Model Number: VICM5 13.2 (-10.0)
• Catalog Number: VICM5 13.2
• Company DUNS: 054751110
• Company Name: STAAR SURGICAL COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841542119412 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030016

FDA Product Code

• MTA: Lens, Intraocular, Phakic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-22
• Device Publish Date: 2022-04-14

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

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