BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSEPT 1-STEP DISINFECTING SOLUTION

    MDR report key: 3954698 · Received July 18, 2014

    Report

    Report Number
    3004178847-2014-00004
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    March 30, 2014
    Report Date
    April 28, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS INC.
    Product Code
    LPN
    PMA / PMN Number
    P850088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED LOT WAS PERFORMED; NO DEVIATIONS WERE NOTED AND PRODUCT MET ALL SPECIFICATIONS. CHEMISTRY EVALUATION RESULTS OF RETAINED UNIT FROM THE REPORTED LOT WERE WITHIN SPECIFICATIONS. MICROBIOLOGY EVALUATION OF RETRAINED UNIT FROM THE REPORTED LOT SHOWED THE SOLUTION TO BE STERILE. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A FEMALE CONSUMER REPORTED THAT AFTER USING CONSEPT 1 STEP DISINFECTING/NEUTRALIZING SYSTEM, HER EYES WERE PAINFUL AND RED. SHE USED THE PRODUCT FOR THREE DAYS AND THEN USED AN OVER THE COUNTER PRODUCT TO TREAT HER SYMPTOMS; SHE DID NOT DISCONTINUE LENS WEAR. SHE ALSO NOTED THAT SHE WASN'T SURE IF THE REDNESS WAS FROM THE PRODUCT OR HAYFEVER. ON (B)(6) 2014, SHE SAW A DOCTOR AND WAS REPORTEDLY DIAGNOSED WITH A BACTERIAL INFECTION. SHE WAS TREATED WITH FLUOROMETHOLONE AND GATIFLOXACIN. SHE DISCONTINUED LENS WEAR FOR FOUR (4) DAYS AND HER EYE RECOVERED. WHEN SHE BEGAN LENS WEAR SHE AGAIN EXPERIENCED OCULAR REDNESS. SHE THEN DISCARDED THE DISINFECTING SOLUTION AND NEUTRALIZING TABLETS BUT DID KEEP THE OUTSIDE BOX THEY WERE PACKAGED IN. SEE COMPANION FILE 2020664-2014-10002 FOR THE NEUTRALIZING TABLETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423089 CONSEPT 1-STEP DISINFECTING SOLUTION HYDROGEN PEROXIDE DISINFECTING SOLUTION LPN ABBOTT MEDICAL OPTICS INC. ZM01650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other