BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AMO PUERTO RICO MANUFACTURING, INC

    Reg #: 2648035 · FEI: 2648035 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    AMO PUERTO RICO MANUFACTURING, INC
    Registration Number
    2648035
    FEI Number
    2648035
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Road 402 N., Industrial Park
    City
    ANASCO
    State
    PR
    ZIP
    00610
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191949
    PMA Number
    P080010

    Owner / Operator

    Firm Name
    Johnson & Johnson Surgical Vision, Inc.
    Operator Number
    10053607
    Address
    31 Technology Dr., Suite 200
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Rosanne Melikian

    Products

    Device Name Product Code
    Lens, Multifocal Intraocular MFK
    Folders And Injectors, Intraocular Lens (Iol) MSS
    Lens, Guide, Intraocular KYB
    Intraocular Lens HQL
    Extended Depth Of Focus Intraocular Lens POE
    Lens, Intraocular, Toric Optics MJP

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device