BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3960183 · Received June 24, 2014

    Report

    Report Number
    2028159-2014-01160
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 26, 2014
    Manufacturer
    ALCON MANUFACTURING, LTD.
    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

    A SAMPLE IS RETURNING AND A SERVICE VISIT HAS BEEN PERFORMED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. NO FURTHER INFORMATION IS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    A PHARMACIST REPORTED THAT DURING SURGERY A SYSTEM MESSAGE WAS DISPLAYED AND MICRO REFLUX WAS NOT AVAILABLE. THE SYSTEM STOPPED PRIMING AND OVER PRESSURE WAS NOT AVAILABLE. THERE WAS A DELAY IN THE CARE OF THE PATIENT. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367379 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON MANUFACTURING, LTD. LXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK TOTAL PLUS PACK, 25+ 5.0 CPM STD| PAK, PRM 23 5.0 CPM