BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2040504 · Received March 18, 2011

    Report

    Report Number
    3003398873-2011-00004
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 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
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE CUSTOMER RETURNED ONE SAMPLE OF PNEUMATIC HANDPIECE. THE (B)(4) FOIL OF THE SAMPLE HAS BEEN REMOVED I.E. THE PACKAGE WAS OPENED WHEN THE INSTRUMENT WAS RECEIVED BY THE COMPANY. THE DEVICE HISTORY RECORD FOR THE AFFECTED LOT WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND AND THE PRODUCT WAS RELEASED ACCORDING TO THE COMPANY'S ACCEPTANCE CRITERIA. ONE HUNDRED PERCENT FINAL INSPECTION IS PERFORMED FOR THIS PRODUCT. THE COMPLAINT HISTORY WAS REVIEWED FOR THE LAST TWO YRS. IT SHOWED COMPARABLE REPORTS. THE DEVICE HISTORY RECORD FOR THE AFFECTED LOT WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND AND THE SAMPLE WAS RELEASED ACCORDING TO THE MFR'S ACCEPTANCE CRITERIA. ONE HUNDRED PERCENT FINAL INSPECTION IS CONDUCTED FOR THIS PRODUCT PRIOR TO RELEASE. THE SAMPLE WAS FUNCTIONALLY AND VISUALLY INSPECTED WITH THE AID OF A PHOTOMICROSCOPE AND WITH VARIOUS MAGNIFICATIONS. THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED. THE PRODUCT MEETS THE SPECIFICATION. TESTING WITH THE COMPLAINT HANDPIECE HAS SHOWN THAT WITH A COMPLETE ATTACHMENT OF A TIP TO THE HANDPIECE THE TIP DOES NOT EJECT FROM THE HANDPIECE. ROOT CAUSE: IT CANNOT BE DETERMINED HOW OR WHERE THE REPORTED DAMAGE OCCURRED. HOWEVER, THE COMPLAINT REPORT IS CONSISTENT WITH A REPORT WHEN THE USER DOES NOT FOLLOW THE DIRECTION FOR USE (DFU) OF THE HANDPIECE. THE DFU STATES THAT FIRST THE TIP HAS TO BE TWISTED COUNTERCLOCKWISE TO THE STOP AND THEN TWISTED CLOCKWISE UNTIL THE DOT OF THE TIP ALIGNS WITH THE MARKING ON THE HANDPIECE. IF THE TIP IS NOT TWISTED COUNTERCLOCKWISE BEFORE TWISTING IT CLOCKWISE, THE TIP MIGHT NOT BE TURNED IN CLOCKWISE DIRECTION. (B)(4).

    Description of Event or Problem · 1

    A COMPANY REP REPORTED ON BEHALF OF A HOSP, THAT DURING SURGERY A DISPOSABLE VERTICAL SCISSOR DETACHED FROM A PNEUMATIC HANDPIECE. THE SCISSOR WAS NOT IN A PT'S EYE WHEN THE EVENT OCCURRED AND THERE WAS NO 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 UNK