CT LUCIA 003500-0050-640

GUDID 00843045100614

3-piece, monofocal, hydrophobic, acrylic, intraocular lens. +4.0D

CARL ZEISS MEDITEC PRODUCTION, LLC

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: 00843045100614
• NIH Device Record Key: ae38c0d2-2526-4ed4-862d-a0ce75e2695d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CT LUCIA
• Version Model Number: CT LUCIA 602.US/+4.0D
• Catalog Number: 003500-0050-640
• Company DUNS: 080685425
• Company Name: CARL ZEISS MEDITEC PRODUCTION, LLC
• 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	00843045100614 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100016

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: 2017-10-01

On-Brand Devices [CT LUCIA]

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• 00843045101055: 3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +26.0D
• 00843045101048: 3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +25.5D
• 00843045101031: 3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +25.0D
• 00843045101024: 3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +24.5D
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• 00843045100959: 3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +21.0D
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• 00843045100928: 3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +19.5D
• 00843045100911: 3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +19.0D
• 00843045100904: 3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +18.5D
• 00843045100898: 3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +18.0D
• 00843045100881: 3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +17.5D
• 00843045100874: 3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +17.0D
• 00843045100867: 3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +16.5D
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• 00843045100799: 3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +13.0D
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• 00843045100775: 3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +12.0D
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• 00843045100751: 3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +11.0D
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• 00843045100737: 3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +10.0D
• 00843045100720: 3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +9.5D