BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOTALCARE DAILY CLEANER

    MDR report key: 2956416 · Received January 30, 2013

    Report

    Report Number
    3004537773-2013-00005
    Event Type
    Other
    Date Received
    January 30, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS INC.
    Product Code
    LPN
    PMA / PMN Number
    P870026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF SOLUTION USED BY 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 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 AVAILABLE PERTINENT INFO HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    OUR (B)(4) OFFICE RECEIVED A CALL FROM A PHARMACIST REPORTING THAT A FEMALE PT WALKED INTO THE PHARMACY AND REPORTED THAT SHE HAD AN ADVERSE EXPERIENCE WHEN SHE USED AN UNK REGIMEN OF TOTALCARE DAILY CLEANER WITH HER SOFT CONTACT LENSES AGAINST MANUFACTURER'S RECOMMENDATIONS. SHE REPORTED THAT SHE EXPERIENCED A BURNED CORNEA, CAN'T WEAR HER CONTACT LENSES AGAIN, AND COULD NOT DRIVE FOR TWO WEEKS. FOLLOW-UP WITH THE PHARMACIST INDICATED THAT THE PT IS NOT THEIR CUSTOMER, BUT "CAME IN OFF THE STREET", AND HE DOES NOT HAVE ANY FURTHER INFO REGARDING THE EVENT, THE COMPLAINT UNIT, OR CONTACT INFO FOR THE PT. USE OF TOTALCARE WITH SOFT CONTACT LENSES IS NOTED ON THE PRODUCT CARTON, BOTTLE AND DIRECTIONS FOR USE: "PRECAUTIONS, DO NOT USE WITH SOFT CONTACT LENSES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40187 TOTALCARE DAILY CLEANER LPN ABBOTT MEDICAL OPTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other