BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3111570 · Received May 6, 2013

    Report

    Report Number
    2028159-2013-00777
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    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
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBE WAS NOT RECEIVED AT THE MFG FACILITY FOR EVAL OF "BUBBLES FROM CUTTER TIP." NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. BECAUSE A SAMPLE HAS NOT BEEN RETURNED AND NO LOT INFO WAS PROVIDED WITH THIS COMPLAINT, THE ROOT CAUSE FOR THE PROBE COMPLAINT ISSUE CANNOT BE DETERMINED. BECAUSE THE ROOT CAUSE IS UNK, NO MALFUNCTION WAS CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    AN EQUIPMENT SPECIALIST REPORTED THAT WHILE THE SURGEON WAS USING THE CUTTER TO ASPIRATE, A SINGLE BUBBLE CAME OUT OF THE TIP EACH TIME THE SURGEON WOULD GO TO POSITION ZERO ON THE FOOT SWITCH DURING SURGERY. THE SURGEON DID NOT REMOVE THE CUTTER FROM EYE. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196201 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25+ GAUGE TOTAL PLUS PAK