Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens

GUDID 00841542102421

Diopter: 21.5; Aspheric; Single Piece

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: 00841542102421
• NIH Device Record Key: 3e5807ea-e8fb-4ca8-8d96-7e812d1f0224
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens
• Version Model Number: CC4204A
• 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	00841542102421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P990013

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 [Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens]

• 00841542102605: Diopter: 30.5; Aspheric; Single Piece
• 00841542102599: Diopter: 30.0; Aspheric; Single Piece
• 00841542102582: Diopter: 29.5; Aspheric; Single Piece
• 00841542102575: Diopter: 29.0; Aspheric; Single Piece
• 00841542102568: Diopter: 28.5; Aspheric; Single Piece
• 00841542102551: Diopter: 28.0; Aspheric; Single Piece
• 00841542102544: Diopter: 27.5; Aspheric; Single Piece
• 00841542102537: Diopter: 27.0; Aspheric; Single Piece
• 00841542102520: Diopter: 26.5; Aspheric; Single Piece
• 00841542102513: Diopter: 26.0; Aspheric; Single Piece
• 00841542102506: Diopter: 25.5; Aspheric; Single Piece
• 00841542102490: Diopter: 25.0; Aspheric; Single Piece
• 00841542102483: Diopter: 24.5; Aspheric; Single Piece
• 00841542102476: Diopter: 24.0; Aspheric; Single Piece
• 00841542102469: Diopter: 23.5; Aspheric; Single Piece
• 00841542102452: Diopter: 23.0; Aspheric; Single Piece
• 00841542102445: Diopter: 22.5; Aspheric; Single Piece
• 00841542102438: Diopter: 22.0; Aspheric; Single Piece
• 00841542102421: Diopter: 21.5; Aspheric; Single Piece
• 00841542102414: Diopter: 21.0; Aspheric; Single Piece
• 00841542102407: Diopter: 20.5; Aspheric; Single Piece
• 00841542102391: Diopter: 20.0 Aspheric; Single Piece
• 00841542102384: Diopter: 19.5; Aspheric; Single Piece
• 00841542102377: Diopter: 19.0; Aspheric; Single Piece
• 00841542102360: Diopter: 18.5; Aspheric; Single Piece
• 00841542102353: Diopter: 18.0; Aspheric; Single Piece
• 00841542102346: Diopter: 17.5; Aspheric; Single Piece
• 00841542102339: Diopter: 17.0; Aspheric; Single Piece
• 00841542102322: Diopter: 16.5; Aspheric; Single Piece
• 00841542102315: Diopter: 16.0; Aspheric; Single Piece
• 00841542102308: Diopter: 15.5; Aspheric; Single Piece
• 00841542102292: Diopter: 15.0; Aspheric; Single Piece
• 00841542102285: Diopter: 14.5; Aspheric; Single Piece
• 00841542102278: Diopter: 14.0; Aspheric; Single Piece
• 00841542102261: Diopter: 13.5; Aspheric; Single Piece
• 00841542102254: Diopter: 13.0; Aspheric; Single Piece
• 00841542102247: Diopter: 12.5; Aspheric; Single Piece
• 00841542102230: Diopter: 12.0; Aspheric; Single Piece
• 00841542102223: Diopter: 11.5; Aspheric; Single Piece
• 00841542102216: Diopter: 11.0; Aspheric; Single Piece
• 00841542102209: Diopter: 10.5; Aspheric; Single Piece
• 00841542102193: Diopter: 30.5; Aspheric; Three Piece
• 00841542102186: Diopter: 30.0; Aspheric; Three Piece
• 00841542102179: Diopter: 29.5; Aspheric; Three Piece
• 00841542102162: Diopter: 29.0; Aspheric; Three Piece
• 00841542102155: Diopter: 28.5; Aspheric; Three Piece
• 00841542102148: Diopter: 28.0; Aspheric; Three Piece
• 00841542102131: Diopter: 27.5; Aspheric; Three Piece
• 00841542102124: Diopter: 27.0; Aspheric; Three Piece
• 00841542102117: Diopter: 26.5; Aspheric; Three Piece