BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE

    MDR report key: 7029050 · Received November 14, 2017

    Report

    Report Number
    2648035-2017-02081
    Event Type
    Malfunction
    Date Received
    November 14, 2017
    Report Date
    November 14, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A TRANSLATION ERROR ON THE BOX/CARTON OF A ZCB00 INTRAOCULAR LENS (IOL). THE BOX/CARTON WAS LABELED AS A DIFFRACTIVE MULTIFOCAL IOL, HOWEVER, THE PRODUCT IS A MONOFOCAL LENS. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810209 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1