BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 2844572 · Received November 12, 2012

    Report

    Report Number
    2028159-2012-01758
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 11, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR THE COMPONENT LOTS WERE REVIEWED. THE ASSOCIATED LOTS (2) WERE RELEASED BASED ON MFR'S ACCEPTABLE CRITERIA PROCESSING ABNORMALITIES WERE DETECTED DURING THE REVIEW. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THREE METAL TUBES DISSOCIATED FROM THE HANDLES OF THE VITRECTOMY DURING SURGERIES. ALL THE METAL TUBES BELONGED TO THE SAME LOT. THERE WAS NO PT IMPACT. ADD'L INFO 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 COMBINED PAK