Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613160

FEI Number

3001284430

Entity Name

LENSTEC BARBADOS, INC.

City/State/Country

CHRIST CHURCH, BB

Establishment Address

AIRPORT COMMERCIAL CENTRE, PILGRIM ROAD, CHRIST CHURCH BB 17092, BB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LENSTEC, INC. (Owner Number: 9032980)

Owner / Operator Contact Address

1765 Commerce Ave N, --, Saint Petersburg, FL 33716, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P200020

All Registered Proprietary Names

Lenstec LC Injection System Softec HD Injection System Softec HDM Softech HDO Softec I TETRAFLEX IOL INJECTION SYSTEM LC INJECTION SYSTEM SOFTEC IOL INJECTION SYSTEM ClearView 3

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2017-10-27
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2010-04-23
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2010-04-23
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2003-03-19
MFK	Lens, Multifocal Intraocular	Ophthalmic	Class 3	886.3600	2022-08-04

Official Correspondent

JIMMY CHACKO

US Agent Details

JIMMY Chacko Business: LENSTEC, INC. Email: jchacko@lenstec.com Phone: (727) 5712272

Related Public Records

Same Entity

LENSTEC, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1063199	LENSTEC, INC.	Saint Petersburg, FL, US

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613160. Last updated year: 2026. Please use registration number 9613160 when referencing this establishment in official correspondence.