Visian ICL (Implantable Collamer Lens)

GUDID 00841542103282

Diopter: -9.5; Overall Diameter (Length): 13.2 mm

STAAR SURGICAL COMPANY

Posterior-chamber intraocular lens, phakic

• Primary Device ID: 00841542103282
• NIH Device Record Key: bd2a7c62-f72c-4fb5-9e33-a123385df8d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visian ICL (Implantable Collamer Lens)
• Version Model Number: MICL 13.2
• 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	00841542103282 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-20

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

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