BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Multifocal Intraocular

    PMA: P040020 · Supplement: S010 · Decision Jun 20, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Lens, Multifocal Intraocular
    Trade Name
    ACRYSOF RESTOR IQ IOL
    PMA Number
    P040020
    Supplement Number
    S010
    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
    June 20, 2008
    Date Received
    April 15, 2008
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGING THE TRADE NAME OF THE DEVICE FROM ACRYSOF RESTOR ASPHERIC APODIZED DIFFRACTIVE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) TO ACRYSOF IQ RESTOR APODIZED DIFFRACTIVE POSTERIOR CHAMBER IOL. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF IQ RESTOR APODIZED DIFFRACTIVE POSTERIOR CHAMBER IOL, MODEL SN6AD3, AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG 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 SPECTACLE INDEPENDENCE.

    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