BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3193136 · Received June 25, 2013

    Report

    Report Number
    2028159-2013-01258
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    ALCON ¿ IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND COULD NOT REPLICATE THE CUSTOMER REPORTED EVENT. THE COMPANY REP PERFORMED A VISUAL AND FUNCTIONAL CHECK OF THE LASER MODULE AND ACCESSORIES, BUT DID NOT IDENTIFY ANY NONCONFORMANCE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. THE SYSTEM EVENT LOG WAS REVIEWED AND DID NOT CONFIRM THE REPORTED EVENT. THE EVENT LOG SHOWED NO ABNORMAL ACTIVITY. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE LASER KEPT FIRING, DURING A PROCEDURE, EVEN AFTER SURGEON HAD REMOVED HIS FOOT FROM THE FOOTPEDAL. THE EMERGENCY STOP BUTTON WAS USED TO STOP THE LASER. THERE WAS NO PT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288741 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON ¿ IRVINE TECHNOLOGY CENTER LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1