BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM PAK

    MDR report key: 1230201 · Received November 13, 2008

    Report

    Report Number
    1644019-2008-00034
    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
    OTHER

    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 FIVE PATIENTS HAVE NOW 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 68 YR Required Intervention IOL| LEGACY| BSS