BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVEREST LEGACY

    MDR report key: 4152468 · Received October 6, 2014

    Report

    Report Number
    2028159-2014-01798
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    ALCON -IRVINE TECH CTR
    Product Code
    HQC
    PMA / PMN Number
    K952213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED, BUT HAS NOT YET BEEN EVALUATED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT THERE WAS LEAKAGE FROM THE CASSETTE DURING PRIMING. THERE WAS NO PT INVOLVED. IT WAS NOTED THAT THE PRODUCT HAD BEEN USED FOUR TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622160 EVEREST LEGACY PHACOFRAGMENTATION SYS HQC ALCON -IRVINE TECH CTR STTL BA

    Patients

    Seq Age Sex Outcome Treatment
    1