BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2801411 · Received October 18, 2012

    Report

    Report Number
    2028159-2012-01620
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYS AND REPLACED THE PNEUMATIC MODULE. THE COMPANY REP ALSO ADJUSTED THE TRAY ARM LOCKS. THE SYS WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE REPLACED PNEUMATIC MODULE WAS RETURNED FOR EVAL. VISUAL ASSESSMENT OF THE RETURNED SAMPLE DID NOT REVEAL ANY NONCONFORMITY. THE RETURNED PNEUMATICS MODULE WAS INSTALLED INTO A CALIBRATED SYS AND TESTED. THE PNEUMATICS MODULE WAS RECOGNIZED BY THE SYS AND NO SYS MESSAGES WERE OBSERVED DURING OR AFTER BOOT UP. ADDITIONAL TESTING WAS PERFORMED AND THE PNEUMATICS MAIN PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) FAILED TO START UP FIVE TIMES DURING THE COLD TEST. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYS. THE ROOT CAUSE IS A NONCONFORMING PNEUMATICS MAIN PCBA. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING A PROCEDURE, THE SYSTEM SHUT DOWN. THE SYSTEM WAS SWITCHED OUT TO COMPLETE THE CASE RESULTING IN A DELAY (LENGTH UNK). THERE WAS NO HARM TO THE PT.

    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 UNK