BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAUREATE WORLD PHACO SYSTEM

    MDR report key: 2222869 · Received August 10, 2011

    Report

    Report Number
    2028159-2011-00925
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID NOT REQUEST SERVICE. NO SAMPLES WERE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    A NURSING ASSISTANT REPORTED THE SYSTEM SHUT OFF AND COULD NOT BE RESTARTED PRIOR TO BEGINNING THE PROCEDURE. THE SURGEON OPTED NOT TO CANCEL THE CASE AND TO PERFORM AN EXTRA CAPSULAR CATARACT EXTRACTION (ECCE) INSTEAD. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAUREATE WORLD PHACO SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER LAUREATE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR