BEUDAMED
    FDA Adverse Event Other Summary report: N

    OXYSEPT 1 STEP DISINFECTING SOLN

    MDR report key: 2685425 · Received July 30, 2012

    Report

    Report Number
    3004178847-2012-00006
    Event Type
    Other
    Date Received
    July 30, 2012
    Date of Event
    June 25, 2012
    Report Date
    June 27, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS INC
    Product Code
    LPN
    PMA / PMN Number
    P850088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF SOLUTION USED BY PT IS UNK; IT WAS DISCARDED. IT IS UNK IF THE DEVICE FAILED TO MEET SPECIFICATIONS AS WE HAVE NOT RECEIVED THE COMPLAINT SAMPLE FOR ANALYSIS NOR HAVE WE RECEIVED 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 RECEIVED THE COMPLAINT SAMPLE FOR ANALYSIS, NOR HAVE WE RECEIVED AN IDENTIFYING LOT NUMBER TO GUIDE OUR TESTING, WE HAVE BEEN UNABLE TO DETERMINE THE RELATIONSHIP. ROOT CAUSE HAS NOT BEEN ESTABLISHED. ALL PERTINENT INFORMATION THAT IS AVAILABLE HAS BEEN SUBMITTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THAT CHANGES THE FACTS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    OUR OFFICE IN (B)(4) REPORTED THAT A FEMALE PT EXPERIENCED A SWOLLEN, RED EYE AND HAD PROBLEMS WITH HER VISION AFTER USING OXYSEPT 1 STEP DISINFECTING SOLUTION; SHE FAILED TO ADD THE NEUTRALIZING TABLET (MISUSE). SHE SAW A DOCTOR AND REPORTED SHE HAD A "MASSIVE INFECTION"; SHE WAS TREATED WITH ISOPTO-MAX AND A 'PAINKILLER' AND TOLD NOT TO WEAR HER CONTACT LENSES FOR A WEEK. THE PT DISCARDED THE BOTTLE OF SOLUTION; THE LOT NUMBER IS UNK. FOLLOW UP INFORMATION FROM THE TREATING DOCTOR HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYSEPT 1 STEP DISINFECTING SOLN LPN ABBOTT MEDICAL OPTICS INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other PROCLEAR SOFT CONTACT LENSES