Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1038833

FEI Number

1038833

Entity Name

EYEKON MEDICAL, INC.

City/State/Country

CLEARWATER, FL, US

Establishment Address

2451 Enterprise Rd, CLEARWATER, FL 33763, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

EYEKON MEDICAL, INC. (Owner Number: 1038833)

Owner / Operator Contact Address

2451 ENTERPRISE RD., Clearwater, FL 33763, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P880072

All Registered Proprietary Names

CTR-12 Blue CTR-10 CTR-10 Blue CTR-12 EyeKon 1 Injector EyeKon-2.2 IOL Injector Acuity MTH Isotechnics Suncoast EyeKon MDR DGR Cirrus Acurus MDR MTH Isotechnics EyeKon Suncoast Acurus Acuity Cirrus DGR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRJ	Ring, Endocapsular	Unknown	Class 3	N/A	2010-07-09
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2016-02-01
MFK	Lens, Multifocal Intraocular	Ophthalmic	Class 3	886.3600	2007-12-05
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2007-12-05

Official Correspondent

Mark Robinson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EYEKON MEDICAL, INC.

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

View Entity Profile →

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.

Similar Registrations

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1225124	FCI OPHTHALMICS, INC.	Pembroke, MA, US
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 1038833. Last updated year: 2026. Please use registration number 1038833 when referencing this establishment in official correspondence.