Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614546

FEI Number

3004651700

Entity Name

AMO GRONINGEN BV

City/State/Country

GRONINGEN, NL

Establishment Address

Van Swietenlaan 5, GRONINGEN 9728 NX, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Johnson & Johnson Surgical Vision, Inc. (Owner Number: 10053607)

Owner / Operator Contact Address

31 Technology Dr., Suite 200, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P080010

All Registered Proprietary Names

IMPLANT, EYE VALVE IMPLANT, EYE VALVE LENS, MULTIFOCAL INTRAOCULAR

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	2019-10-17
KYF	Implant, Eye Valve	Ophthalmic	Class 2	886.3920	2016-12-22
KYF	Implant, Eye Valve	Ophthalmic	Class 2	886.3920	2016-12-22
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2016-12-22
POE	Extended Depth Of Focus Intraocular Lens	Ophthalmic	Class 3	886.3600	2016-12-22
MJP	Lens, Intraocular, Toric Optics	Ophthalmic	Class 3	886.3600	2016-12-22
MFK	Lens, Multifocal Intraocular	Ophthalmic	Class 3	886.3600	2016-12-22
MFK	Lens, Multifocal Intraocular	Ophthalmic	Class 3	886.3600	2016-12-22

Official Correspondent

Rosanne Melikian

US Agent Details

Rosanne Melikian Business: Johnson & Johnson Vision Email: RegulatoryImplantsMailBox01@its.jnj.com Phone: (714) 3138856

Related Public Records

Same Entity

Johnson & Johnson Surgical Vision, 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
3005675890	OptiMedica Corp.	Milpitas, CA, US
3004750704	AMO UPPSALA AB	UPPSALA, SE
3008169506	TearScience, Inc.	Milpitas, CA, US
3011714173	AMO (HANGZHOU PARK) WAREHOUSE	Hangzhou Zhejiang, CN
3004178847	AMO (HANGZHOU) CO., LTD.	HANGZHOU Zhejiang, CN

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
2523835	Alcon Research, LLC	Sinking Spring, PA, US
3012236936	Johnson & Johnson Surgical Vision, Inc.	Irvine, CA, US
1610287	Alcon Research, LLC	Fort Worth, TX, US
9681862	MEDICEL AG	Altenrhein Sankt Gallen, CH
1932180	Bausch & Lomb Incorporated	Manchester, MO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614546. Last updated year: 2026. Please use registration number 9614546 when referencing this establishment in official correspondence.