BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE MPS EASY RUB FORMULA

    MDR report key: 1640940 · Received March 23, 2010

    Report

    Report Number
    2020664-2010-00006
    Event Type
    Injury
    Date Received
    March 23, 2010
    Date of Event
    November 7, 2008
    Report Date
    February 24, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS INC
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT OBTAINED FROM MAUDE DATABASE. IS THE EPIDEMIC OF ACANTHAMOEBA KERATITIS OVER? 2008 OMIG, ABSTRACT 17. DAVID RITTERBAND MD, WILMA PEREZ BS, JOHN SEEDOR MD, RICHARD KOPLIN MD, (B) (4). LOT NUMBER OF SOLUTION USED BY THE PT IS UNK, AND THE MFR DOES NOT HAVE ANY PT INFO THAT WOULD ALLOW US TO FURTHER OUR INVESTIGATION OF LOT NUMBER AND ADVERSE EVENT DETAILS. IT IS UNK IF THE DEVICE FAILED TO MEET SPECS AS WE HAVE NOT REC'D THE COMPLAINT SAMPLE FOR ANALYSIS NOR HAVE WE REC'D AN IDENTIFYING LOT NUMBER TO PERFORM PRODUCT INVESTIGATION. THE DEVICE WAS MOST PROBABLY BEING USED FOR TREATMENT, AS THIS TYPE OF DEVICE IS NOT TYPICALLY USED FOR DIAGNOSIS. THE RELATIONSHIP, IF ANY, OF THE DEVICE TO THE REPORTED INCIDENT/ADVERSE EVENT IS UNK. THE COMPLAINANT REPORTED AN ASSOCIATION BETWEEN THE AMO DEVICE AND THE REPORTED EVENT. HOWEVER, BECAUSE WE HAVE NOT REC'D THE COMPLAINT SAMPLE FOR ANALYSIS, NOR HAVE WE REC'D AN IDENTIFYING LOT NUMBER TO GUIDE OUR TESTING, WE HAVE BEEN UNABLE TO DETERMINE THE RELATIONSHIP. ROOT CAUSE HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    A REVIEW OF THE MAUDE DATABASE REVEALED A POSTER PRESENTED AT THE 2008 YEARLY MEETING OF OCULAR MICROBIOLOGY AND IMMUNOLOGY GROUP (OMIG) ENTITLED "IS THE EPIDEMIC OF ACANTHAMOEBA KERATITIS OVER". IT PROVIDED INFO THAT 10 PTS WERE DIAGNOSED WITH ACANTHAMOEBA KERATITIS AT A HOSP IN 2008. TWO PTS HAD USED COMPLETE MULTI-PURPOSE SOLUTION EASY RUB FORMULA (THIS REPORT AND 2020664-2010-00005), AND ONE USED COMPLETE MOISTUREPLUS (SUBMITTED TO FDA ON RAE LINE LISTING, MARCH 2010). ADDITIONALLY, IT REPORTED THAT FIVE OF THE PTS DIAGNOSED WITH AK USED RENU MULTIPLUS, AND TWO WERE USING ALCON OPTI-FREE REPLENISH (ONE PT WAS NOT A CL WEARER). ADD'L INFO HAS BEEN REQUESTED FROM REPORTER/AUTHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE MPS EASY RUB FORMULA LPN ABBOTT MEDICAL OPTICS INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention