Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1225124

FEI Number

3000210020

Entity Name

FCI OPHTHALMICS, INC.

City/State/Country

Pembroke, MA, US

Establishment Address

30 Corporate Park Drive, Suite #310/320, Pembroke, MA 02359, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

K162361

PMA Number

N/A

All Registered Proprietary Names

Morcher CTR EZYPOR FCI Prolong Plug

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRJ	Ring, Endocapsular	Unknown	Class 3	N/A	2020-04-06
HPZ	Implant, Eye Sphere	Ophthalmic	Class 2	886.3320	2022-06-24
LZU	Plug, Punctum	Unknown	Class U	N/A	2019-07-17

Official Correspondent

No official correspondent registered.

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
3010126268	Carl Zeiss Meditec Production, LLC.	Ontario, CA, US
2918630	CARL ZEISS MEDITEC INC	DUBLIN, CA, US
9615010	CARL ZEISS MEDITEC AG (OBERKOCHEN)	OBERKOCHEN Baden-Wurttemberg, DE

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2007	Integrated Orbital Implants Inc	2	Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S

Similar Registrations

Registration Number	Establishment Name	Location
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1038833	EYEKON MEDICAL, INC.	CLEARWATER, FL, US
3015456951	Alcon Laboratories Belgium	Puurs-Sint-Amands Antwerpen, BE
3006017180	BBF STERILISATIONSSERVICE GMBH	Kernen Baden-Wurttemberg, DE
3005941719	Sterigenics Belgium Petit Rechain S.A.	Verviers Liege, BE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1225124. Last updated year: 2026. Please use registration number 1225124 when referencing this establishment in official correspondence.