BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOTALCARE DALILY CLEANER

    MDR report key: 2820869 · Received April 30, 2012

    Report

    Report Number
    3004537773-2012-00004
    Event Type
    Other
    Date Received
    April 30, 2012
    Date of Event
    March 15, 2012
    Report Date
    March 21, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS INC
    Product Code
    LPN
    PMA / PMN Number
    P870026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF THE SOLUTION USED BY PATIENT IS UNKNOWN. THE REPORTER INDICATES THE BOTTLE WAS PROBABLY DISCARDED. IT IS UNKNOWN IF THE DEVICE FAILED TO MEET SPECIFICATION AS WE HAVE NOT RECEIVED THE COMPLAINT SAMPLE FOR ANALYSIS NOR HAVE WE RECEIVED AN IDENTIFYING LOT NUMBER TO PERFORM THE 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 UNKNOWN. 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. THE ROOT CAUSE HAS NOT BEEN ESTABLISHED, HOWEVER, THIS DEVICE IS NOT INDICATED TO BE USED AS A STORAGE SOLUTION FOR GAS PERMEABLE CONTACT LENSES. PATIENT MISUSE OF THE PRODUCT MAY HAVE CONTRIBUTED TO THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    OUR OFFICE IN THE (B)(6) REPORTED A WIFE INDICATED HER HUSBAND STORED HIS GAS PERMEABLE CONTACT LENSES IN TOTALCARE DAILY CLEANER FOR 10 DAYS (MISUSE). HE RINSED THE LENSES WITH SALINE AND PLACED THEM IN HIS EYES. HE EXPERIENCED IRRITATION, PAIN AND REDNESS AND SUBSEQUENTLY SOUGHT TREATMENT AT AN EMERGENCY ROOM. IN FOLLOW UP IT WAS LEARNED THAT HE WAS TOLD THAT THE 'ENTIRE TOP LAYER OF THE EYE WAS BURNT OFF'. THE PATIENT'S EYES WERE IRRIGATED WITH SALINE AND ANTIBIOTICS (BRAND NOT RECALLED) WERE PRESCRIBED. EIGHT DAYS FOLLOWING THE EVENT, THE WIFE REPORTED THAT SHE THOUGHT HER HUSBAND'S VISION WAS STILL 'FOGGY' AND SHE WAS NOT SURE IF HE HAD RESUMED LENS WEAR; HE WAS OUT OF THE COUNTRY ON A BUSINESS TRIP. SHE BELIEVED THE COMPLAINT UNIT WAS DISCARDED; THE LOT NUMBER IS UNKNOWN. ADDITIONAL INFORMATION FROM THE PATIENT HAS BEEN REQUESTED BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTALCARE DALILY CLEANER LPN ABBOTT MEDICAL OPTICS INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other