Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2648035

FEI Number

2648035

Entity Name

AMO PUERTO RICO MANUFACTURING, INC

City/State/Country

ANASCO, PR, US

Establishment Address

Road 402 N., Industrial Park, ANASCO, PR 00610, US

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

P960028

All Registered Proprietary Names

LENS, MULTIFOCAL INTRAOCULAR FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) LENS, GUIDE, INTRAOCULAR LENS, GUIDE, INTRAOCULAR intraocular lens intraocular lens LENS, MULTIFOCAL INTRAOCULAR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MFK	Lens, Multifocal Intraocular	Ophthalmic	Class 3	886.3600	2016-12-22
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2019-10-17
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2016-12-22
KYB	Lens, Guide, Intraocular	Ophthalmic	Class 1	886.4300	2016-12-22
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	Class 1	886.4300	2016-12-22
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2016-12-22
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	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

No US Agent registered (Local establishment).

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
9614546	AMO GRONINGEN BV	GRONINGEN, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K823222	American Medical Optics	INTRAOCULAR LENS GUIDE	1982-12-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0835-2025	Alcon Research LLC	1	Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch III D delivery cartridge Lens Guide, Intraocular Component: N/A
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
3015456951	Alcon Laboratories Belgium	Puurs-Sint-Amands Antwerpen, BE
9612169	ALCON LABORATORIES IRELAND LTD.	CORK, IE
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 2648035. Last updated year: 2026. Please use registration number 2648035 when referencing this establishment in official correspondence.