BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALCON

    MDR report key: 2050311 · Received April 6, 2011

    Report

    Report Number
    MW5020205
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 7, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ALCON
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS RECEIVING RIGHT CATARACT WITH IOL REMOVAL AND VITRECTOMY. DURING VITRECTOMY, THE VITRECTOMY MACHINE MALFUNCTIONED. MACHINE WAS NOT ASPIRATING, BUT WAS INFUSING. AS A RESULT, THE PT WAS LEFT WITH FRAGMENTS OF LENS SITTING ON HIS RETINA. PT WILL HAVE 'FLOATERS' AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON VITRECTOMY MACHINE HQC ALCON ACCU RUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability