BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PAK

    MDR report key: 3063327 · Received March 1, 2013

    Report

    Report Number
    1644019-2013-00019
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 4, 2013
    Manufacturer
    ALCON MANUFACTURING, LTD.
    Product Code
    KYG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR THE COMPONENT LOTS WERE REVIEWED. (B)(4). NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THE "NEEDLE WAS FOUND TO BE OFF BECAUSE OF ADHESION FAILURE" DURING SURGERY. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT. ADD'L INFO HAD BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90184 CUSTOM PAK CONVENIENCE KIT KYG ALCON MANUFACTURING, LTD. CUSTOM PAK 1345139H

    Patients

    Seq Age Sex Outcome Treatment
    1 CONSTELLATION VISION SYSTEM| TOTAL PLUS PAK 25+ 5.0 CPM VALVED STANDARD