BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3131124 · Received May 23, 2013

    Report

    Report Number
    2028159-2013-01015
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SYSTEM TURNED OFF DURING A PROCEDURE. THERE WAS NO PATIENT HARM. THE CUSTOMER STATES, "IT WAS DUE TO HAVING A UPS OF 10 AMPS WHILE ALL THE MACHINERY IN THE ROOM IS CONNECTED TO IT. IT WAS CLARIFIED THAT THE ISSUE WAS NOT RELATED TO THE CONSTELLATION RATHER THAN THE UPS." ADD'L INFO RECEIVED ON 30-APR-2013. THE PROCEDURE WAS ABORTED BEFORE THE LASER COULD BE PERFORMED ON THE PATIENT AND THE WOUND WAS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229674 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON-IRVINE TECHNOLOGY CENTER LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other