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Sign in to claim this brandCarl Zeiss Meditec Production, LLC
US
Last updated May 23, 2026
What Carl Zeiss Meditec Production, LLC makes
The company manufactures posterior-chamber intraocular lenses (pseudophakic) and reusable manual intraocular lens injectors, including associated insertion cartridges. These devices are designed for cataract surgery to replace the natural lens and facilitate precise lens implantation.
The portfolio includes devices authorised under FDA’s Class I and Class III regulations, with some listed under the 510(k) exemption and others requiring Premarket Approval (PMA). Products are also registered in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Carl Zeiss Meditec Production, LLC primarily manufacture?
Carl Zeiss Meditec Production, LLC specialises in devices used during cataract surgery. Their portfolio includes posterior-chamber intraocular lenses (pseudophakic), which replace the natural lens after removal, and reusable manual intraocular lens injectors designed to precisely implant these lenses. They also produce associated insertion cartridges to facilitate the process.
Where is Carl Zeiss Meditec Production, LLC based, and how does that affect its regulatory oversight?
The company is based in the United States, which means its devices fall under FDA regulatory jurisdiction. Since the FDA oversees medical devices in the US, the manufacturer’s location determines the regulatory pathways—such as Premarket Approval (PMA) for Class III devices or 510(k) exemptions for Class I devices—applicable to their products.
Which regulatory registries or databases list Carl Zeiss Meditec Production, LLC’s devices?
The company’s devices are registered in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance tracking. Additionally, some of their products are authorised under the FDA’s Premarket Approval (PMA) process, while others may qualify for the 510(k) exemption, depending on their classification.
How are Carl Zeiss Meditec Production, LLC’s devices classified under FDA regulations?
The company’s devices are classified under both FDA Class I and Class III regulations. Class I devices generally pose minimal risk and may be exempt from certain premarket submissions, while Class III devices—like some intraocular lenses—require rigorous premarket approval due to higher associated risks, such as potential complications from implantation.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 080685425
Catalogue (194)
Page 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ct Lucia | CT LUCIA 621P.AM DPT 24.0 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 602.US/+5.0D | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 602.US/+32.0D | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 611P.AM DPT 05.5 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 602.US/+27.0D | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 611P.AM DPT 18.5 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 621P.AM DPT 19.5 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 602.US/+6.0D | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 621P.AM DPT 15.0 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 602.US/+13.5D | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 611P.AM DPT 22.0 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 611P.AM DPT 25.5 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 602.US/+19.5D | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 611P.AM DPT 33.0 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 602.US/+5.5D | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 611P.AM DPT 14.0 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 602.US/+18.5D | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 611P.AM DPT 23.5 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 621P.AM DPT 20.5 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 602.US/+13.0D | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 611P.AM DPT 30.0 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 621P.AM DPT 10.0 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 602.US/+33.0D | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 611P.AM DPT 15.5 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 621P.AM DPT 19.0 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 611P.AM DPT 24.5 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 621P.AM DPT 18.0 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 602.US/+15.0D | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 602.US/+30.5D | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 621P.AM DPT 03.5 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 611P.AM DPT 08.5 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 602.US/+10.5D | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 602.US/+27.5D | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 611P.AM DPT 04.0 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 602.US/+29.5D | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 621P.AM DPT 21.5 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 611P.AM DPT 32.0 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 602.US/+23.0D | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 602.US/+28.5D | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 611P.AM DPT 27.0 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 611P.AM DPT 20.5 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 621P.AM DPT 05.5 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 611P.AM DPT 08.0 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 621P.AM DPT 06.0 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 621P.AM DPT 16.5 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 621P.AM DPT 12.0 | FDA UDI | Class III | Active |
| Z Cartridge IOL Delivery System - Cartridge | Z28 | FDA UDI | Class I | Active |
| Ct Lucia | CT LUCIA 621P.AM DPT 14.5 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 621P.AM DPT 09.5 | FDA UDI | Class III | Active |
| Ct Lucia | CT LUCIA 621P.AM DPT 31.0 | FDA UDI | Class III | Active |
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