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

GUDID 00841542104906

Diopter: -11.5; Cylinder 2.0; Overall Diameter (Length): 12.1

STAAR SURGICAL COMPANY

Posterior-chamber intraocular lens, phakic

• Primary Device ID: 00841542104906
• NIH Device Record Key: 75f73347-5990-4106-aa9e-6e09af5713b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visian Toric ICL (Implantable Collamer Lens for Myopia)
• Version Model Number: TMICL12.1 (-11.5/2.0)
• 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	00841542104906 [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)]

• 00084154211291: Diopter: -17.5; Cylinder 4.0; Overall Diameter (Length): 13.7
• 00841542112369: Diopter: -18.0; Cylinder 4.0; Overall Diameter (Length): 13.7
• 00841542112284: Diopter: -17.5; Cylinder 3.5; Overall Diameter (Length): 13.7
• 00841542112277: Diopter: -17.5; Cylinder 3.0; Overall Diameter (Length): 13.7
• 00841542112222: Diopter: -17.0; Cylinder 4.0; Overall Diameter (Length): 13.7
• 00841542112215: Diopter: -17.0; Cylinder 3.5; Overall Diameter (Length): 13.7
• 00841542112208: Diopter: -17.0; Cylinder 3.0; Overall Diameter (Length): 13.7
• 00841542112192: Diopter: -17.0; Cylinder 2.5; Overall Diameter (Length): 13.7
• 00841542112185: Diopter: -17.0; Cylinder 2.0; Overall Diameter (Length): 13.7
• 00841542112154: Diopter: -16.5; Cylinder 4.0; Overall Diameter (Length): 13.7
• 00841542112147: Diopter: -16.5; Cylinder 3.5; Overall Diameter (Length): 13.7
• 00841542112130: Diopter: -16.5; Cylinder 3.0; Overall Diameter (Length): 13.7
• 00841542112123: Diopter: -16.5; Cylinder 2.5; Overall Diameter (Length): 13.7
• 00841542112116: Diopter: -16.5; Cylinder 2.0; Overall Diameter (Length): 13.7
• 00841542112109: Diopter: -16.5; Cylinder 1.5; Overall Diameter (Length): 13.7
• 00841542112093: Diopter: -16.5; Cylinder 1.0; Overall Diameter (Length): 13.7
• 00841542112086: Diopter: -16.0; Cylinder 4.0; Overall Diameter (Length): 13.7
• 00841542112079: Diopter: -16.0; Cylinder 3.5; Overall Diameter (Length): 13.7
• 00841542112062: Diopter: -16.0; Cylinder 3.0; Overall Diameter (Length): 13.7
• 00841542112055: Diopter: -16.0; Cylinder 2.5; Overall Diameter (Length): 13.7
• 00841542112048: Diopter: -16.0; Cylinder 2.0; Overall Diameter (Length): 13.7
• 00841542112031: Diopter: -16.0; Cylinder 1.5; Overall Diameter (Length): 13.7
• 00841542112024: Diopter: -16.0; Cylinder 1.0; Overall Diameter (Length): 13.7
• 00841542112017: Diopter: -15.5; Cylinder 4.0; Overall Diameter (Length): 13.7
• 00841542112000: Diopter: -15.5; Cylinder 3.5; Overall Diameter (Length): 13.7
• 00841542111997: Diopter: -15.5; Cylinder 3.0; Overall Diameter (Length): 13.7
• 00841542111980: Diopter: -15.5; Cylinder 2.5; Overall Diameter (Length): 13.7
• 00841542111973: Diopter: -15.5; Cylinder 2.0; Overall Diameter (Length): 13.7
• 00841542111966: Diopter: -15.5; Cylinder 1.5; Overall Diameter (Length): 13.7
• 00841542111959: Diopter: -15.5; Cylinder 1.0; Overall Diameter (Length): 13.7
• 00841542111942: Diopter: -15.0; Cylinder 4.0; Overall Diameter (Length): 13.7
• 00841542111935: Diopter: -15.0; Cylinder 3.5; Overall Diameter (Length): 13.7
• 00841542111928: Diopter: -15.0; Cylinder 3.0; Overall Diameter (Length): 13.7
• 00841542111911: Diopter: -15.0; Cylinder 2.5; Overall Diameter (Length): 13.7
• 00841542111904: Diopter: -15.0; Cylinder 2.0; Overall Diameter (Length): 13.7
• 00841542111898: Diopter: -15.0; Cylinder 1.5; Overall Diameter (Length): 13.7
• 00841542111881: Diopter: -15.0; Cylinder 1.0; Overall Diameter (Length): 13.7
• 00841542111874: Diopter: -14.5; Cylinder 4.0; Overall Diameter (Length): 13.7
• 00841542111867: Diopter: -14.5; Cylinder 3.5; Overall Diameter (Length): 13.7
• 00841542111850: Diopter: -14.5; Cylinder 3.0; Overall Diameter (Length): 13.7
• 00841542111843: Diopter: -14.5; Cylinder 2.5; Overall Diameter (Length): 13.7
• 00841542111836: Diopter: -14.5; Cylinder 2.0; Overall Diameter (Length): 13.7
• 00841542111829: Diopter: -14.5; Cylinder 1.5; Overall Diameter (Length): 13.7
• 00841542111812: Diopter: -14.5; Cylinder 1.0; Overall Diameter (Length): 13.7
• 00841542111805: Diopter: -14.0; Cylinder 4.0; Overall Diameter (Length): 13.7
• 00841542111799: Diopter: -14.0; Cylinder 3.5; Overall Diameter (Length): 13.7
• 00841542111782: Diopter: -14.0; Cylinder 3.0; Overall Diameter (Length): 13.7
• 00841542111775: Diopter: -14.0; Cylinder 2.5; Overall Diameter (Length): 13.7
• 00841542111768: Diopter: -14.0; Cylinder 2.0; Overall Diameter (Length): 13.7
• 00841542111751: Diopter: -14.0; Cylinder 1.5; Overall Diameter (Length): 13.7