BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECHNIS LENS

    MDR report key: 2823751 · Received August 4, 2008

    Report

    Report Number
    2823751
    Event Type
    Malfunction
    Date Received
    August 4, 2008
    Date of Event
    July 25, 2008
    Report Date
    August 4, 2008
    Manufacturer
    ADVANCE MEDICAL OPTICS (AMO)
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MULTIFOCAL LENS WAS PACKAGED IN TECHNISE LENS PACKAGING BY THE MFR. THE INCORRECT LENS WAS THEN IMPLANTED INTO THE PT'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECHNIS LENS NONE HQL ADVANCE MEDICAL OPTICS (AMO)

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other