Visian Toric ICL (Implantable Collamer Lens for Myopia TMICL12.1

GUDID 00841542105316

Diopter: -14.5; Cylinder 1.5; Overall Diameter (Length): 12.1

STAAR SURGICAL COMPANY

Posterior-chamber intraocular lens, phakic

• Primary Device ID: 00841542105316
• NIH Device Record Key: dd905b95-a64a-4d04-ba29-a07e2433aa56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visian Toric ICL (Implantable Collamer Lens for Myopia
• Version Model Number: TMICL 12.1 (-14.5/1.5)
• Catalog Number: TMICL12.1
• Company DUNS: 054751110
• Company Name: STAAR SURGICAL COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841542105316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030016

FDA Product Code

• QCB: Phakic Toric Intraocular Lens

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: 2018-11-19
• Device Publish Date: 2018-10-17

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

• 00841542105859: Diopter: -18.0; Cylinder 4.0; Overall Diameter (Length): 12.1
• 00841542105842: Diopter: -18.0; Cylinder 3.5; Overall Diameter (Length): 12.1
• 00841542105538: Diopter: -16.0; Cylinder 2.0; Overall Diameter (Length): 12.1
• 00841542105378: Diopter: -15.0; Cylinder 1.0; Overall Diameter (Length): 12.1
• 00841542105316: Diopter: -14.5; Cylinder 1.5; Overall Diameter (Length): 12.1
• 00841542104951: Diopter: -12.0; Cylinder 1.0; Overall Diameter (Length): 12.1
• 00841542104784: Diopter: -10.5; Cylinder 3.0; Overall Diameter (Length): 12.1
• 00841542104630: Diopter: -9.5; Cylinder 2.5; Overall Diameter (Length): 12.1
• 00841542104319: Diopter: -7.0; Cylinder 4.0; Overall Diameter (Length): 12.1
• 00841542104036: Diopter: -5.0; Cylinder 4.0; Overall Diameter (Length): 12.1
• 00841542104012: Diopter: -5.0; Cylinder 3.0; Overall Diameter (Length): 12.1
• 00841542104005: Diopter: -5.0; Cylinder 2.5; Overall Diameter (Length): 12.1
• 00841542103992: Diopter: -5.0; Cylinder 2.0; Overall Diameter (Length): 12.1
• 00841542103985: Diopter: -5.0; Cylinder 1.5; Overall Diameter (Length): 12.1
• 00841542103978: Diopter: -5.0; Cylinder 1.0; Overall Diameter (Length): 12.1