BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2357991 · Received November 9, 2011

    Report

    Report Number
    2028159-2011-01359
    Event Type
    Malfunction
    Date Received
    November 9, 2011
    Report Date
    October 10, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS THE FIRST COMPLAINT REPORTED FOR THIS ISSUE. THERE ARE THREE ADDITIONAL REPORTS AGAINST THE FINISHED GOODS LOT. THE ORDER WAS BUILT AND RELEASED PER SPECIFICATION. THE CUSTOMER DID NOT RETAIN A SAMPLE TO RETURN FOR INVESTIGATION; THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS INCIDENT. (B)(4).

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE(MEDICAL TRAINER) WAS INFORMED BY A SURGEON THAT A "CONSIDERABLE"LEAK OF BALANCED SALT SOLUTION (BSS) OCCURRED DURING SURGERY. BSS SOLUTION WAS NOTED "FLOWING DOWN" THE LASER MODULE, NEAR THE EMERGENCY SWITCH. THERE WAS NO ERROR MESSAGE DISPLAYED BY THE SYSTEM AT THE TIME OF THE EVENT. THE SURGERY WAS COMPLETED AND THERE WAS NO PT HARM 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