Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens - Toric Optic

GUDID 00841542100540

Diopter: 9.5 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)

STAAR SURGICAL COMPANY

Posterior-chamber intraocular lens, pseudophakic

• Primary Device ID: 00841542100540
• NIH Device Record Key: 70c5fe0b-810e-4316-b019-d631962f24b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens - Toric Optic
• Version Model Number: AA4203TL
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841542100540 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P880091

FDA Product Code

• MJP: Lens, Intraocular, Toric Optics

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

Devices Manufactured by STAAR SURGICAL COMPANY

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• 00840311300150 - EVO/EVO+VISIAN Implantable Collamer Lens: 2023-12-08 VICM5 - Diopter: -4.0; Overall Diameter (Length): 12.1
• 00840311300167 - EVO/EVO+VISIAN Implantable Collamer Lens: 2023-12-08 VICM5 - Diopter: -4.5; Overall Diameter (Length): 12.1
• 00840311300174 - EVO/EVO+VISIAN Implantable Collamer Lens: 2023-12-08 VICM5 - Diopter: -5.0; Overall Diameter (Length): 12.1
• 00840311300181 - EVO/EVO+VISIAN Implantable Collamer Lens: 2023-12-08 VICM5 - Diopter: -5.5; Overall Diameter (Length): 12.1
• 00840311300228 - EVO/EVO+VISIAN Implantable Collamer Lens: 2023-12-08 VICM5 - Diopter: -7.5; Overall Diameter (Length): 12.1
• 00840311300235 - EVO/EVO+VISIAN Implantable Collamer Lens: 2023-12-08 VICM5 - Diopter: -8.0; Overall Diameter (Length): 12.1
• 00840311300297 - EVO/EVO+VISIAN Implantable Collamer Lens: 2023-12-08 VICM5 - Diopter: -11.0; Overall Diameter (Length): 12.1