BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2040519 · Received March 18, 2011

    Report

    Report Number
    2028159-2011-00256
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND NO PROBLEMS WERE FOUND. THE EVENT LOG WAS CHECKED AND NO SYSTEM MESSAGES WERE FOUND. THE COMPANY REP REVIEWED THE EVENT WITH THE NURSE AND THE NURSE STATED THE PROBE WAS SWITCHED OUT AND THAT RESOLVED THE PROBLEM REPORTED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE ROOT CAUSE IS UNK AT THIS TIME. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 03/18/2011. (B)(4).

    Description of Event or Problem · 1

    A COMPANY REP REPORTED ON BEHALF OF A SURGEON THAT BOTH COLD LIGHT MODULES DIDN'T WORK IN ANY OF THE FOUR PORTS. THE SYSTEM WAS REBOOTED AND THE PROBE WAS EXCHANGED, WITHOUT SUCCESS. LATER AFTER REBOOTING AND EXCHANGING THE PAK, THE LIGHT MODULES DID WORK AND THE SURGERY WAS COMPLETED AFTER A ONE HR DELAY. ADDITIONAL INFO RECEIVED INDICATED THAT THE LIGHT MODULE WORKED AFTER INSERTING IT AGAIN, AND THE MACHINE HAS WORKED WITHOUT PROBLEMS SINCE THE EVENT OCCURRED. ON A LATER DATE, FURTHER INFO RECEIVED INDICATED THAT THE PT'S OUTCOME LOOKS GOOD, THAT THE PT TOLERATED THE SURGERY VERY WELL. THERE WERE NO SPECIAL MEASURES TAKEN, AND THE PT TOLERATED THE PROLONGED ANESTHESIA.

    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 UNK