BEUDAMED
    FDA Adverse Event Other Summary report: N

    OXYSEPT 1 STEP NEUTRALIZING TABLETS

    MDR report key: 3808252 · Received April 30, 2012

    Report

    Report Number
    2020664-2012-10006
    Event Type
    Other
    Date Received
    April 30, 2012
    Date of Event
    January 1, 2012
    Report Date
    April 18, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS INC
    Product Code
    LPN
    PMA / PMN Number
    P850088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. MANUFACTURER OF REPORTED DEVICE PERFORMED CHEMISTRY EVALUATIONS OF THE ACTUAL PRODUCT USED BY THE CONSUMER; ALL RESULTS WERE WITHIN SPECIFICATIONS. CHEMISTRY EVALUATION RESULTS OF RETAINED UNIT FROM THE REPORTED LOT WERE WITHIN SPECIFICATIONS. THE ROOT CAUSE HAS NOT BEEN ESTABLISHED. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    OUR OFFICE IN THE (B)(6) REPORTED A FEMALE PATIENT EXPERIENCED AN OCULAR BURNING SENSATION AFTER USING OXYSEPT 1 STEP DISINFECTING SOLUTION AND OXYSEPT 1 STEP NEUTRALIZING TABLETS. SHE INDICATED SHE USED THE PRODUCTS PER THE DIRECTIONS FOR USE, INSERTED HER LENSES AND EXPERIENCED THE BURNING SENSATION. SHE IRRIGATED HER EYES WITH SALINE AND SOUGHT TREATMENT AT AN EMERGENCY ROOM. SHE LATER RELATED THAT HER DIAGNOSIS WAS A CORNEAL BURN. SHE HAD 3 FOLLOW UP VISITS TO MONITOR HER EYES. SHE WAS TREATED WITH UNSPECIFIED ANTIBIOTICS, ANTINFLAMMATORIES AND ARTIFICIAL TEARS; FOURTEEN DAYS LATER SHE INDICATED SHE WAS '80% BETTER'. FOLLOW UP WITH HER HEALTH CARE PROFESSIONAL HAS BEEN REQUESTED BUT NOT RECEIVED. SEE COMPANION MDR (B)(4) FOR OXSEPT 1 STEP DISINFECTING SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYSEPT 1 STEP NEUTRALIZING TABLETS LPN ABBOTT MEDICAL OPTICS INC 32209

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CONTOR-NISSEL| CONTACT LENSES| HYDROGEL