BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3063319 · Received March 1, 2013

    Report

    Report Number
    2028159-2013-00342
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 12, 2013
    Manufacturer
    ALCON MANUFACTURING, LTD.
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE PROBLEM REPORTED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. 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. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SYSTEM MESSAGE WAS DISPLAYED WHEN THE LASER CORD WAS PULLED DURING A VITRECTOMY PROCEDURE. "THE COMPUTER RESTARTS AND IT FAILS TO REPRODUCE BUT DO NOT SHOW AGAIN." THE SYSTEM WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90654 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON MANUFACTURING, LTD. LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1