BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2861637 · Received November 29, 2012

    Report

    Report Number
    2028159-2012-01866
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE VERIFIED A BROKEN LAMP AND REPLACED THE TABLE TOP ILLUMINATOR. THE COMPANY REPRESENTATIVE HAD NOTED THAT THE LAMP WAS PREVIOUSLY REPLACED AND HAD 14 HOURS ON IT. THE SYSTEM WAS THEN TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. NO SAMPLES WERE RETURNED FOR EVALUATION. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION 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 ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE OF REPORTED EVENT IS A NONCONFORMING LAMP. (B)(4).

    Description of Event or Problem · 1

    AN OPERATING ROOM COORDINATOR REPORTED THAT THERE WAS NO TABLE TOP ILLUMINATION AFTER HEARING A LOUD POP FRO THE MODULE DURING A VITREO-RETINAL PROCEDURE. IT IS UNKNOWN IF THERE WAS ANY IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN PROVIDED TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1