Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens

GUDID 00841542101578

Diopter: 10.5 Overall Diameter (Length): 11.2 mm (Longer Haptic)

STAAR SURGICAL COMPANY

Posterior-chamber intraocular lens, pseudophakic

• Primary Device ID: 00841542101578
• NIH Device Record Key: 06759bae-1f1e-447a-af05-1c2cce769eb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elastic UV-Absorbing Silicone Posterior Chamber Intraocular Lens
• Version Model Number: AA4204VL
• 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	00841542101578 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P880091

FDA Product Code

• HQL: Intraocular Lens

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]

• 00841542101783: Diopter: 21.0 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101776: Diopter: 20.5 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101769: Diopter: 20.0 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101752: Diopter: 19.5 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101745: Diopter: 19.0 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101738: Diopter: 18.5 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101721: Diopter: 18.0 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101714: Diopter: 17.5 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101707: Diopter: 17.0 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101691: Diopter: 16.5 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101684: Diopter: 16.0 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101677: Diopter: 15.5 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101660: Diopter: 15.0 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101653: Diopter: 14.5 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101646: Diopter: 14.0 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101639: Diopter: 13.5 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101622: Diopter: 13.0 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101615: Diopter: 12.5 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101608: Diopter: 12.0 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101592: Diopter: 11.5 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101585: Diopter: 11.0 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101578: Diopter: 10.5 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101561: Diopter: 10.0 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101554: Diopter: 9.5 Overall Diameter (Length): 11.2 mm (Longer Haptic)
• 00841542101547: Diopter: 30.5 Overall Diameter (Length): 10.8 mm
• 00841542101530: Diopter: 30.0 Overall Diameter (Length): 10.8 mm
• 00841542101523: Diopter: 29.5 Overall Diameter (Length): 10.8 mm
• 00841542101516: Diopter: 29.0 Overall Diameter (Length): 10.8 mm
• 00841542101509: Diopter: 28.5 Overall Diameter (Length): 10.8 mm
• 00841542101493: Diopter: 28.0 Overall Diameter (Length): 10.8 mm
• 00841542101486: Diopter: 27.5 Overall Diameter (Length): 10.8 mm
• 00841542101479: Diopter: 27.0 Overall Diameter (Length): 10.8 mm
• 00841542101462: Diopter: 26.5 Overall Diameter (Length): 10.8 mm
• 00841542101455: Diopter: 26.0 Overall Diameter (Length): 10.8 mm
• 00841542101448: Diopter: 25.5 Overall Diameter (Length): 10.8 mm
• 00841542101431: Diopter: 25.0 Overall Diameter (Length): 10.8 mm
• 00841542101424: Diopter: 24.5 Overall Diameter (Length): 10.8 mm
• 00841542101417: Diopter: 24.0 Overall Diameter (Length): 10.8 mm
• 00841542101400: Diopter: 23.5 Overall Diameter (Length): 10.8 mm
• 00841542101394: Diopter: 23.0 Overall Diameter (Length): 10.8 mm
• 00841542101387: Diopter: 22.5 Overall Diameter (Length): 10.8 mm
• 00841542101370: Diopter: 22.0 Overall Diameter (Length): 10.8 mm
• 00841542101363: Diopter: 21.5 Overall Diameter (Length): 10.8 mm