BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 3915508 · Received February 26, 2014

    Report

    Report Number
    2028159-2014-00310
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 30, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTS DURING A PROCEDURE THE VITRECTOMY CUTTER HAD POOR ACCUATION. SURGERY WAS COMPLETED WITH AN ALTERNATE VITRECTOMY PROBE WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118249 ACCURUS 400VS PHACOFRAGMENTATION SYS HQC ALCON - IRVINE TECHNOLOGY CTR ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25G| PROBE| ENH| STANDALONE