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CT Lucia 602, CT Lucia 202, CT Lucia 611P

FDA PMA

Class III (US FDA PMA)

PMA P100016

by Carl Zeiss Meditec Production, LLC

Identity

Trade Name
EC-3 INTRAOCULAR LENS (IOL) AND EC-3 PRECISION ASPHERIC LENS (PAL) IOL FDA PMA
Generic Name
intraocular lens FDA PMA

Identifiers

PMA Number
P100016 FDA PMA
FDA Product Code
HQL FDA PMA

Classification

Device Class
Class III FDA PMA
Legislation / Framework
21 CFR Part 886.3600 FDA PMA
Regulation Number
886.3600 FDA PMA
Advisory Committee
Ophthalmic FDA PMA
FDA Decision
APPR Approved FDA PMA

The device is an intraocular lens (IOL) indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. It includes the EC-3 intraocular lens and EC-3 precision aspheric lens (PAL) IOL models.

Supplied as a sterile, single-use implant for ophthalmic surgical use. Authorized under FDA PMA P100016, manufactured by Carl Zeiss Meditec Production, LLC in Ontario, CA, and classified as a Class III device under regulation number 886.3600.

Frequently asked questions

What is the intended use of the CT Lucia 602, 202, and 611P intraocular lenses?

The CT Lucia 602, 202, and 611P models are indicated for primary implantation in the capsular bag of the eye to correct aphakia in adult patients who have undergone cataractous lens removal, as specified in the device's approval documentation.

Are the CT Lucia intraocular lenses reusable or single-use?

The device is supplied as a sterile, single-use implant intended for one-time surgical implantation and is not designed for reuse.

What regulatory authorization covers the CT Lucia intraocular lens models?

The CT Lucia 602, 202, and 611P intraocular lenses are authorized under FDA Premarket Approval (PMA) number P100016, which approved the EC-3 intraocular lens and EC-3 precision aspheric lens (PAL) for the stated indication.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Carl Zeiss Meditec Production, LLC

Sources (1)

  • FDA PMA P100016 24 fields · synced Oct 6, 2026