Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2031474

FEI Number

3002023310

Entity Name

TEKIA, INC.

City/State/Country

Irvine, CA, US

Establishment Address

17 Hammond, suite 414, Irvine, CA 92618, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

TEKIA, INC (Owner Number: 10023535)

Owner / Operator Contact Address

17 Hammond, suite 414, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TEKLENS II Three Piece Hydrophlic Acrylic IOLs Model 600 & 600Y Series TEK-CLEAR Accommodative IOLs Model 500 Series TEKTOR Single Piece Acrylic Toric IOLs Model 820 &820Y TEKLENS III Hydrophobic Acrylic IOLs Model 900 series TEKLENS II Single Piece Hydrophlic Acrylic IOLs Model 800 & 800Y Series

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2007-11-29

Official Correspondent

gene currie

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TEKIA, 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

Registration Number	Establishment Name	Location
3013202565	AAREN SCIENTIFIC INC	Rancho Cucamonga, CA, US
3015456951	Alcon Laboratories Belgium	Puurs-Sint-Amands Antwerpen, BE
1313525	Bausch & Lomb Incorporated	Rochester, NY, US
9612169	ALCON LABORATORIES IRELAND LTD.	CORK, IE
3007530141	Alcon Research, LLC	Lesage, WV, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2031474. Last updated year: 2026. Please use registration number 2031474 when referencing this establishment in official correspondence.