BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 1191494 · Received September 26, 2008

    Report

    Report Number
    1644019-2008-00029
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Report Date
    August 27, 2008
    Manufacturer
    ALCON HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED, WHEN ADDTIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE SURGEON REPORTED LINT FIBERS PRESENT IN THE EYE DURING THE POST-OP EXAM. THE SURGEON STATED THAT THE PATIENT IS DOING WELL, AND NOT AFFECTED BY THE FOREIGN MATERIAL. THE SURGEON ALSO STATED THAT THERE ARE NO PLAINS ON REMOVING THE FOREIGN MATERIAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM PAK CONVENIENCE KIT KYG ALCON HOUSTON CUSTOM PAK 786419H

    Patients

    Seq Age Sex Outcome Treatment
    1