Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010126268

FEI Number

3010126268

Entity Name

Carl Zeiss Meditec Production, LLC.

City/State/Country

Ontario, CA, US

Establishment Address

1040 S VINTAGE AVE BLDG A, Ontario, CA 91761, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Carl Zeiss Meditec AG (Jena) (Owner Number: 9053564)

Owner / Operator Contact Address

Goeschwitzer Strasse 51-52, Jena, DE-TH 07745, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P100016

All Registered Proprietary Names

CT LUCIA 601P CT LUCIA 202 CT LUCIA 211P CT LUCIA 201PY CT LUCIA 201P CT LUCIA 611P CT LUCIA 611PY CT LUCIA 211PY CT LUCIA 601PY CT LUCIA 621PY CT LUCIA 221P CT LUCIA 621P intraocular lens CT LUCIA 602 CT LUCIA 202 CT LUCIA 611P CT LUCIA 621P

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2017-02-06
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2015-01-06

Official Correspondent

Carl ZEISS Meditec AG (Jena)

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Carl Zeiss Meditec AG (Jena)

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015534077	Carl Zeiss Meditec Digital Innovations Inc	Temple, TX, US
3032734659	Carl Zeiss Meditec (Suzhou) Co., Ltd.	Suzhou Jiangsu, CN
2918630	CARL ZEISS MEDITEC INC	DUBLIN, CA, US
9615010	CARL ZEISS MEDITEC AG (OBERKOCHEN)	OBERKOCHEN Baden-Wurttemberg, DE
3004467263	FCI SUD	MAPOU LECLEZIO GOODLANDS Riviere du Rempart, MU

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0275-2012	Abbott Medical Optics Inc (AMO)	3	Sensar Foldable IOL with OptiEdge. Model number AR40e, 6.0 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.
Z-0276-2012	Abbott Medical Optics Inc (AMO)	3	Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ultraviolet-absorbing posterior chamber intraocular lenses and are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens are intended to be placed in a capsular bag.
Z-0605-2010	Abbott Medical Optics Inc (AMO)	3	AMO Tecnis 1-Piece Intraocular Lens (Model ZCB00)
Z-0929-2013	Abbott Medical Optics Inc (AMO)	3	AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.
Z-2287-2020	Alcon Research LLC Aspex Facility	3	Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.

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1313525	Bausch & Lomb Incorporated	Rochester, NY, US
9612169	ALCON LABORATORIES IRELAND LTD.	CORK, IE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010126268. Last updated year: 2026. Please use registration number 3010126268 when referencing this establishment in official correspondence.