BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYSEPT 1 STEP DISINFECTING SOLUTION

    MDR report key: 1672878 · Received April 29, 2010

    Report

    Report Number
    2020664-2010-00017
    Event Type
    Malfunction
    Date Received
    April 29, 2010
    Report Date
    February 1, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS, INC.
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE MET ALL CHEMISTRY SPECS INCLUDING APPEARANCE. THIS IS THE ONLY COMPLAINT REC'D FOR THIS LOT NUMBER. THE NEUTRALIZING TABLETS WERE NOT TESTED BECAUSE THEY WERE BEYOND THEIR EXPIRATION DATE. THIS IS THE ONLY COMPLAINT REC'D FOR THIS LOT NUMBER.

    Description of Event or Problem · 1

    OUR OFFICE IN (B) (4) REPORTED (B) (6) MALE CONSUMER INDICATED HIS WOEHLK GEAFLEX CONTACT LENSES HAD FUNGAL GROWTH ON THEM WHILE USING THE OXYSEPT DISINFECTING SYSTEM. HE NOTED THAT THIS WAS THE SECOND TIME THIS HAD OCCURRED. HE ALSO NOTED THAT THERE WERE BLACK DOTS IN THE SOLUTION IN HIS LENS CASE. IN FOLLOW UP IT WAS LEARNED THAT HE ROUTINELY STORED HIS CONTACT LENSES FOR 6 DAYS AND DID NOT CLEAN HIS LENS CASE PER DIRECTIONS FOR USE. HE SENT HIS LENSES TO THE CONTACT LENS MFR FOR ANALYSIS. THE REPORT FOUND MIXED DEPOSITS, JELLY BUMPS AND FUNGAL GROWTH. THE CONTACT LENS MFR RECOMMENDED A MANUAL CLEANING STEP WITH EITHER STERILE SALINE OR A PRODUCT SUCH AS BLINK-N-CLEAN AND CONTINUING USE OF A HYDROGEN PEROXIDE DISINFECTION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYSEPT 1 STEP DISINFECTING SOLUTION LPN ABBOTT MEDICAL OPTICS, INC. NA ZD02636

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR HYDROGEN PEROXIDE VENTED CONTACT LENS CASE| OXYSEPT 1 STEP NEUTRALIZING TABLETS: LOT 18276,| EXPIRATION: 10/31/2009