BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2913587 · Received December 21, 2012

    Report

    Report Number
    2028159-2012-02028
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 29, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS THE ONLY COMPLAINT REPORTED FOR THIS ISSUE. THIS IS 1 OF 2 COMPLAINTS OF THIS NATURE REPORTED AGAINST THE FINISHED GOODS LOT AND THE DEVICE HISTORY RECORD (DHR) SHOWS THE PRODUCT WAS RELEASED PER SPECIFICATIONS. THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS COMPLAINT REPORT; FUNCTIONAL TESTING COULD NOT BE CONDUCTED. IT IS NOT KNOWN WHAT CAUSED THE REPORTED BUBBLES IN THE EYE DURING SURGERY. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS NOT KNOWN; A SAMPLE WAS NOT RETURNED FOR THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED BUBBLES IN A PATIENT'S EYE DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 25+ GAUGE TOTAL PLUS PAK 5.0 CPM