BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P980040 · Supplement: S023 · Decision May 27, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    TECNIS ONE-PIECE INTRAOCULAR LENS, MODEL ZCB00
    PMA Number
    P980040
    Supplement Number
    S023
    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
    May 27, 2008
    Date Received
    March 21, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REVISIONS TO THE LABELING FOR THE TECNIS ONE-PIECE INTRAOCULAR LENS, MODEL ZCB00 AS FOLLOWS: 1) MODIFICATIONS TO THE DEVICE DESCRIPTION SECTION TO INCLUDE AN ADDITIONAL DESCRIPTION OF WAVEFRONT-DESIGNED ASPHERIC OPTIC, SQUARED POSTERIOR OPTIC EDGE, FROSTED OPTIC EDGE, AN OPTICAL IMAGE QUALITY GRAPH FOR THE ASPHERIC OPTIC; 2) MODIFICATIONS TO THE ADVERSE EVENTS SAND THE CLINICAL TRIAL SECTIONS TO REFLECT DATA FROM THE ONE-YEAR CLINICAL STUDY RESULTS; AND 3) OTHER ADMINISTRATIVE CHANGES SUCH AS THE REWORDING OF THE LAST SENTENCE ON PAGE 1, ADDING TRADEMARKS TO THE DETAILED DEVICE DESCRIPTION SECTION AND REVISION THE NUMBERING OF THE FIGURES.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens