BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS

    MDR report key: 4102177 · Received September 17, 2014

    Report

    Report Number
    2028159-2014-01725
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Report Date
    August 19, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PHACO TIP (UNSPECIFIED ITEM) WAS RETURNED FOR METAL FLAKES IN THE EYE. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT; THEREFORE, A LOT HISTORY REVIEW COULD NOT BE CONDUCTED. BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT INFORMATION WAS PROVIDED FOR A LOT RECORD REVIEW, THE ROOT CAUSE FOR CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED METAL FLAKES FOUND IN A PATIENT'S EYE AFTER CATARACT SURGERY. THE DOCTOR SUSPECTS THEY CAME FROM THE PHACO TIP. THERE WAS NO HARM TO THE PATIENT. IT IS UNKNOWN WHAT SYSTEM WAS BEING USED AT THE TIME OF THIS EVENT BUT ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT WILL BE FILED AGAINST ACCURUS AS THE LAST FEW SERVICE REPORTS HAVE BEEN AGAINST THE ACCURUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575987 ACCURUS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK