BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Multifocal Intraocular

    PMA: P040020 · Supplement: S050 · Decision Apr 13, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Lens, Multifocal Intraocular
    Trade Name
    ACRYSOF IQ RESTOR +2.5 D MULTIFOCAL INTRAOCULAR LENS
    PMA Number
    P040020
    Supplement Number
    S050
    Device Class
    FDA Class 3
    Product Code
    MFK
    Generic Name
    Lens, multifocal intraocular
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 13, 2015
    Date Received
    August 30, 2013
    Supplement Type
    Panel Track
    Expedited Review
    N
    Docket Number
    15M-1325

    Advisory Committee Statement

    APPROVAL FOR THE ACRYSOF® IQ RESTOR® +2.5 D MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL SV25T0. THIS DEVICE IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO REMOVAL OF A CATARACTOUS LENS IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA, WHO DESIRE NEAR, INTERMEDIATE AND DISTANCE VISION WITH INCREASED SPECTACLEINDEPENDENCE.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MFK Lens, Multifocal Intraocular