BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 1230200 · Received November 13, 2008

    Report

    Report Number
    1644019-2008-00036
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 14, 2008
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. THIS REPORT WAS MAILED TO FDA ON: 11/13/2008.

    Description of Event or Problem · 1

    THE FACILITY REPORTED 5 PATIENTS HAVE NOW BEEN DIAGNOSED WITH TASS. WE ARE LOOKING AT EVERYTHING THAT WAS USED DURING THE PROCEDURES, CUSTOM PAKS AND BSS. WE ARE ALSO LOOKING AT OUR PROCESS. FOLLOW-UP INFO WAS REC'D IN 2008: FULL VISUAL ACUITY HAS BEEN ACHIEVED AND THE PT CONTINUES TREATMENT WITH TOPICAL STEROIDS. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention BSS| LEGACY| IOL