BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P980040 · Supplement: S015 · Decision Oct 30, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    SENSAR & TECNIS ONE-PIECE ACRYLIC POSTERIOR CHAMBER IOLS (MODELS AAB00 & ZCB00)
    PMA Number
    P980040
    Supplement Number
    S015
    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
    October 30, 2007
    Date Received
    May 18, 2007
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR TWO NEW MODELS OF SENSAR SOFT ACRYLIC UV LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS) AND THE CLAIMS FOR REDUCED POSTOPERATIVE SPHERICAL ABERRATIONS AND IMPROVED NIGHT-DRIVING SIMULATOR PERFORMANCE. THE NEW MODELS ARE SENSAR ONE-PIECE ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL AAB00) AND TECNIS ONE-PIECE ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL ZCB00). THE TWO MODELS DIFFER FROM THE PARENT MODELS AS FOLLOWS: SINGLE PIECE DESIGN, THE ADDITION OF A SURFACE TREATMENT TO THE ACRYLIC MATERIAL, AND SLIGHT REDUCTION IN THE CENTER THICKNESS WITH ZERO ANGULATION.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens