BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 286951 · Received July 20, 2000

    Report

    Report Number
    1644019-2000-00027
    Event Type
    Malfunction
    Date Received
    July 20, 2000
    Report Date
    June 20, 2000
    Manufacturer
    ALCON - HOUSTON
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RPTR NOTED THE SURGEON HAS OBSERVED PIECES OF PLASTIC MATERIAL IN THE PT'S EYE SEVERAL TIMES. ONCE, THE PLASTIC PIECE WAS NOT REMOVED AND AN INFLAMMATORY REACTION OCCURRED. NO INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TWENTY THOUSAND LEGACY OPHTHALMIC SURGERY SYSTEM HQE ALCON - HOUSTON STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO