BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P930014 · Supplement: S084 · Decision Sep 29, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRELOADED DELIVERY SYSTEM
    PMA Number
    P930014
    Supplement Number
    S084
    Device Class
    FDA Class 3
    Product Code
    HQL
    Generic Name
    intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 29, 2015
    Date Received
    August 7, 2015
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE ACRYSERT C DELIVERY SYSTEM BY REDUCING THE SIZE OF THE NOZZLE TIP, ADDING AN EXTERNAL NOZZLE TIP DEPTH GUARD, AND ADDING A PLUNGER SPRING AND PLUNGER LOCK, THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ACRYSOF IQ ASPHERIC INTRAOCULAR LENS WITH ULTRASERT PRELOADED DELIVERY SYSTEM. THE ACRYSOF IQ POSTERIOR CHAMBER INTRAOCULAR LENSES ARE INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS TO ACHIEVE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS FOLLOWING CATARACT SURGERY. THE LENS IS INTENDED FOR PLACEMENT IN THE CAPSULAR BAG.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens