Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612169

FEI Number

3002808262

Entity Name

ALCON LABORATORIES IRELAND LTD.

City/State/Country

CORK, IE

Establishment Address

CORK BUSINESS AND TECHNOLOGY PARK, MODEL FARM RD., CORK -, IE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Alcon Laboratories, Inc. (Owner Number: 1610287)

Owner / Operator Contact Address

6201 South Freeway, Fort Worth, TX 76134, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P930014

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MFK	Lens, Multifocal Intraocular	Ophthalmic	Class 3	886.3600	2006-02-28
MJP	Lens, Intraocular, Toric Optics	Ophthalmic	Class 3	886.3600	2006-02-28
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2006-02-28
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2021-01-07
MJP	Lens, Intraocular, Toric Optics	Ophthalmic	Class 3	886.3600	2021-01-07
MFK	Lens, Multifocal Intraocular	Ophthalmic	Class 3	886.3600	2021-01-07
POE	Extended Depth Of Focus Intraocular Lens	Ophthalmic	Class 3	886.3600	2021-01-07
POE	Extended Depth Of Focus Intraocular Lens	Ophthalmic	Class 3	886.3600	2007-11-21
MFK	Lens, Multifocal Intraocular	Ophthalmic	Class 3	886.3600	2007-11-21
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2007-11-21
MJP	Lens, Intraocular, Toric Optics	Ophthalmic	Class 3	886.3600	2007-11-21

Official Correspondent

No official correspondent registered.

US Agent Details

Dale Schaper Business: ALCON LABORATORIES, INC. Email: dale.schaper@alcon.com Phone: (817) 5686421

Related Public Records

Same Entity

Alcon Laboratories, 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
3013497605	Alcon Research, LLC	Sinking Spring, PA, US
3003701944	OPTONOL, LTD	NEVE ILAN Central, IL
3016232028	LUMITHERA, INC.	Fort Worth, TX, US
3006186389	CIBA VISION JOHOR SDN.BHD.,	GELANG PATAH, JOHOR DARUL TAKZIM, MY
3016075957	IVANTIS, INC.	Irvine, CA, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2022	Johnson & Johnson Surgical Vision Inc	3	TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile, disposable insertion system for delivering the IOL into the eye during cataract surgery.
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.

Similar Registrations

Registration Number	Establishment Name	Location
3012236936	Johnson & Johnson Surgical Vision, Inc.	Irvine, CA, US
2648035	AMO PUERTO RICO MANUFACTURING, INC	ANASCO, PR, US
3015456951	Alcon Laboratories Belgium	Puurs-Sint-Amands Antwerpen, BE
3007530141	Alcon Research, LLC	Lesage, WV, US
1119279	Bausch & Lomb Incorporated	CLEARWATER, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612169. Last updated year: 2026. Please use registration number 9612169 when referencing this establishment in official correspondence.