BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3994063 · Received July 24, 2014

    Report

    Report Number
    2028159-2014-01366
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. A SAMPLE HAS BEEN RECEIVED, BUT HAS NOT YET BEEN EVALUATED. THE DEVICE HISTORY RECORDS (DHR) FOR THE LOTS WERE REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER COMPLAINT ISSUE WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO THE MFR'S ACCEPTANCE CRITERIA. A ROOT CAUSE HAS NOT YET BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT THE BLADE OF THE CUTTER WAS DULL SOON AFTER USAGE EVEN THOUGH PRIMING HAD BEEN PERFORMED WITHOUT PROBLEMS. THE PROBLEM WAS SOLVED AFTER REPLACING THE CUTTER WITH ANOTHER ONE. THERE WAS NO HARM TO THE PT. NO FURTHER INFO IS EXPECTED FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435297 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR LXT-JAPAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 TOTAL PLUS PAK 25+ 5.0 CPM VALVED STD J