BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOTALCARE DAILY CLEANER

    MDR report key: 2956425 · Received January 30, 2013

    Report

    Report Number
    3004537773-2013-00004
    Event Type
    Other
    Date Received
    January 30, 2013
    Date of Event
    January 1, 2012
    Report Date
    October 24, 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, AS THE MFR HAS NOT RECEIVED THE LOT NUMBER OR 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 PERTINENT INFO HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    OUR OFFICE IN (B)(6) RECEIVED A REPORT THAT A PT HAD MISTAKENLY USED TOTALCARE DAILY CLEANER TO STORE HER LENSES (LENS TYPE UNK) OVERNIGHT, THEN APPLIED THEM WITHOUT RINSING, CONTRARY TO THE MANUFACTURER'S SUGGESTED REGIMEN. THE PT WAS ADVISED BY THE DISPENSING PHARMACY TO GO TO A HOSPITAL EMERGENCY ROOM FOR TREATMENT. ADDITIONAL INFO HAS BEEN REQUESTED OF THE PT REGARDING HER TREATMENT, AND RESOLUTION OF HER SYMPTOMS, AS WELL AS REQUESTING RETURN OF THE COMPLAINT UNIT; HOWEVER, SHE HAS NOT RESPONDED. FOLLOW-UP WITH THE PHARMACY INDICATED THAT THE PT WAS STILL UNDER THE CARE OF THE PHYSICIAN 17 DAYS AFTER HER INITIAL EXPERIENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40092 TOTALCARE DAILY CLEANER LPN ABBOTT MEDICAL OPTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other