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

GUDID 00841542100557

Diopter: 10.0 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)

STAAR SURGICAL COMPANY

Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic

• Primary Device ID: 00841542100557
• NIH Device Record Key: 6c458ab9-b83c-40cd-a8a0-4b52ff382c6c
• 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	00841542100557 [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

On-Brand Devices [Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens - Toric Optic]

• 00841542101219: Diopter: 23.5 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101202: Diopter: 23.0 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101196: Diopter: 22.5 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101189: Diopter: 22.0 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101172: Diopter: 21.5 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101165: Diopter: 21.0 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101158: Diopter: 20.5 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101141: Diopter: 20.0 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101134: Diopter: 19.5 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101127: Diopter: 19.0 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101110: Diopter: 18.5 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101103: Diopter: 18.0 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101097: Diopter: 17.5 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101080: Diopter: 17.0 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101073: Diopter: 16.5 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101066: Diopter: 16.0 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101059: Diopter: 15.5 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101042: Diopter: 15.0 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101035: Diopter: 14.5 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101028: Diopter: 14.0 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101011: Diopter: 13.5 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101004: Diopter: 13.0 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542100991: Diopter: 12.5 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542100984: Diopter: 12.0 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542100977: Diopter: 11.5 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542100960: Diopter: 11.0 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542100953: Diopter: 10.5 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542100946: Diopter: 10.0 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542100939: Diopter: 9.5 SE/3.5 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542100922: Diopter: 28.5 SE/3.5 Toric; Overall Diameter (Length): 10.8 mm
• 00841542100915: Diopter: 28.0 SE/3.5 Toric; Overall Diameter (Length): 10.8 mm
• 00841542100908: Diopter: 27.5 SE/3.5 Toric; Overall Diameter (Length): 10.8 mm
• 00841542100892: Diopter: 27.0 SE/3.5 Toric; Overall Diameter (Length): 10.8 mm
• 00841542100885: Diopter: 26.5 SE/3.5 Toric; Overall Diameter (Length): 10.8 mm
• 00841542100878: Diopter: 26.0 SE/3.5 Toric; Overall Diameter (Length): 10.8 mm
• 00841542100861: Diopter: 25.5 SE/3.5 Toric; Overall Diameter (Length): 10.8 mm
• 00841542100854: Diopter: 25.0 SE/3.5 Toric; Overall Diameter (Length): 10.8 mm
• 00841542100847: Diopter: 24.5 SE/3.5 Toric; Overall Diameter (Length): 10.8 mm
• 00841542100830: Diopter: 24.0 SE/3.5 Toric; Overall Diameter (Length): 10.8 mm
• 00841542100823: Diopter: 23.5 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542100816: Diopter: 23.0 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542100809: Diopter: 22.5 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542100793: Diopter: 22.0 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542100786: Diopter: 21.5 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542100779: Diopter: 21.0 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542100762: Diopter: 20.5 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542100755: Diopter: 20.0 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542100748: Diopter: 19.5 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542100731: Diopter: 19.0 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542100724: Diopter: 18.5 SE/2.0 Toric; Overall Diameter (Length): 11.2 mm (Longer Haptic)