BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFINITI

    MDR report key: 2061718 · Received April 13, 2011

    Report

    Report Number
    MW5020280
    Event Type
    Other
    Date Received
    April 13, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQC
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SURGICAL CASE BEGAN AND SHORTLY AFTER INFINITI VISION SYSTEM OZIL S/N (B)(4) BECAME LOCKED IN THE IRRIGATING POSITION. IT WOULD NOT STOP THE FLOW OF BSS OUT OF THE I AND A HANDPIECE. PHYSICIAN REQUESTED A REPLACEMENT MACHINE. CASE RESUMED, NO ADVERSE AFFECT TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI INFINITI VISION SYSTEM OZIL HQC ALCON LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR