BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P980040 · Supplement: S041 · Decision Aug 21, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    TECNIS ITEC PRELOADED DELIVERY SYSTEM
    PMA Number
    P980040
    Supplement Number
    S041
    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
    August 21, 2013
    Date Received
    September 4, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE PACKAGING CONFIGURATION/ DELIVERY SYSTEM FOR THE TECNIS® 1-PIECE INTRAOCULAR LENS (IOL), MODEL ZCB00. THE NEW PACKAGING CONFIGURATION WILL FUNCTION AS BOTH THE PRIMARY PACKAGING FOR THE LENS AND AS A STERILE, DISPOSABLE INSERTION SYSTEM FOR DELIVERING THE LENS INTO THE EYE. THE TECNIS® 1-PIECE IOL (MODEL ZCB00) IN THE NEW PACKAGING CONFIGURATION/ DELIVERY SYSTEM IS DESIGNATED THE TECNIS ITEC PRELOADED DELIVERY SYSTEM, MODEL PCB00, AND IS INDICATED FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR CATARACT EXTRACTION. THE LENS IS INTENDED TO BE PLACED 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