Identity
- Trade Name
- CT LUCIA FDA UDI
- Generic Name
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
- Device Name
- 3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +16.0D FDA UDI
- Model / Reference
- CT LUCIA 602.US/+16.0D FDA UDI
- Description
- 3-piece, monofocal, hydrophobic, acrylic, intraocular lens, +16.0D FDA UDI
Identifiers
- Catalog Number
- 003500-0050-664 FDA UDI
- Primary DI / UDI-DI
- 00843045100850 FDA UDI
- PMA Number
- P100016 FDA UDI
- FDA Product Code
- HQL FDA UDI
- GMDN Term
- Posterior-chamber intraocular lens, pseudophakic FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 886.3600 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Posterior-chamber intraocular lens, pseudophakic
Ct Lucia by Carl Zeiss Meditec Production, LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Posterior-chamber intraocular lens, pseudophakic.
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Cleared under the same submission
P100016 also covers:
- CT LUCIA — Carl Zeiss Meditec Production, LLC
- CT LUCIA — Carl Zeiss Meditec Production, LLC
- CT LUCIA — Carl Zeiss Meditec Production, LLC
- CT LUCIA — Carl Zeiss Meditec Production, LLC
- CT LUCIA — Carl Zeiss Meditec Production, LLC
- CT LUCIA — Carl Zeiss Meditec Production, LLC
- CT LUCIA — Carl Zeiss Meditec Production, LLC
- CT LUCIA — Carl Zeiss Meditec Production, LLC
- CT LUCIA — Carl Zeiss Meditec Production, LLC
- CT LUCIA — Carl Zeiss Meditec Production, LLC
- CT LUCIA — Carl Zeiss Meditec Production, LLC
- CT LUCIA — Carl Zeiss Meditec Production, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Carl Zeiss Meditec Production, LLC
Sources (1)
- FDA UDI 21e69c6f-2e4f-486c-aa5f-affd5f1891b7 35 fields · synced Jun 7, 2026