BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1781216 · Received July 29, 2010

    Report

    Report Number
    2028159-2010-01330
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Report Date
    June 29, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD'L INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT AND THE ROOT CAUSE IS THEREFORE UNK AT THIS TIME. A REVIEW OF COMPLAINTS AND SERVICE REQUESTS FOR THE LAST 24 MONTHS INDICATED NO ADD'L, RELATED REPORTS FOR THIS SYSTEM. QUALITY ASSURANCE WILL MONITOR RELATED COMPLAINTS AND WILL TAKE ACTION FOR FURTHER OCCURRENCES AS NECESSARY. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INJURY" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "SYSTEM MESSAGE DISPLAYED" (DEVICE DISPLAYS ERROR MESSAGE). A CUSTOMER REPORTED A SYSTEM MESSAGE OCCURRED DURING A CASE. THE SYSTEM WAS SWAPPED OUT FOR ANOTHER SYSTEM AND THE CASE WAS COMPLETED. AFTER THE CASE WAS COMPLETED, THE CUSTOMER SHUT DOWN THE SYSTEM AND REMOVED THE CASSETTE. FLUID WAS THEN NOTICED AROUND THE CASSETTE HOUSING. THE SYSTEM WAS WIPED OFF AND USED FOR THE REMAINING CASE WITH NO ADD'L PROBLEMS. THE CASSETTE WAS NOT RETAINED FOR EVAL. THERE WAS NO PT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION WITH LASER UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER CONSTELLATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1