BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTALCARE

    MDR report key: 5616234 · Received April 28, 2016

    Report

    Report Number
    3004537773-2016-00005
    Event Type
    Injury
    Date Received
    April 28, 2016
    Report Date
    July 28, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: PRODUCT TESTING WAS NOT PERFORMED AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. MANUFACTURING RECORD: MANUFACTURING RECORDS REVIEW FOR THE REPORTED LOT WAS NOT PERFORMED AS LOT NUMBER OF THE COMPLAINT PRODUCT WAS UNKNOWN. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) OF RIGID GAS PERMEABLE FAMILY (TOTALCARE) WAS REVIEWED. RELATED INSTRUCTION WAS ADDRESSED AND ADEQUATELY PROVIDES PRECAUTIONS AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. A HISTORICAL COMPLAINT REVIEW WAS CONDUCTED. RESULTS REVEALED NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR COMPLAINTS OF THE REPORTED ISSUE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    LOT NUMBER: UNKNOWN, NOT PROVIDED. EXPIRATION DATE: UNKNOWN. (B)(4). DEVICE MANUFACTURE DATE: UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A REPORT RECEIVED FROM (B)(6), THAT A CUSTOMER, WHO DID NOT WISH TO SHARE THEIR PERSONAL CONTACT INFORMATION, REPORTED AN ISSUE WITH AMO TOTAL DAILY CLEANER. THE REPORT TO (B)(6) STATED: "NOTABLY, AS YOU SHOULD SEE FROM DOCUMENTS PROVIDED TO YOU BY AMO, TOTAL CARE DAILY CLEANER'S PH IS 9, WHICH IS QUITE STRONGLY ALKALINE AND EXPLAINS WHY MY HEALTH WAS COMPLETELY DECIMATED BY THIS PRODUCT. I HAVE BEEN CONFIRMED AS HAVING TRIGEMINAL NEUROPATHY (DUE TO TRANSFERENCE OF ENORMOUS PAIN TO THE TRIGEMINAL NERVE WHILE MY EPITHELIAL (FRONT OF MY CORNEA) WAS DISSOLVED), I ALSO HAVE EXTREME ANXIETY, DEPRESSION AND PTSD. LITERALLY, MY LIFE IS RUINED. I'M A PRISONER INDOORS (THE MILDEST BREEZE RESULTS IN AGONY FOR DAYS FOR ME). IT'S A DISASTER. I REALLY DON'T WANT ANYONE ELSE TO EVER SUFFER NEEDLESSLY FROM THIS, ESPECIALLY AS ALL IT TAKES IS FOR THE MANUFACTURER TO VERY INEXPENSIVELY COMPLY WITH ISO 18369-1 WITH REGARD TO LABELING...AND UNDERSTAND THAT REFERRING ON THE OUTSIDE OF A BOX TO RGP LENSES AS SIMPLY GAS PERMEABLE LENSES WHEN MOST LENSES NOWADAYS ARE GAS-PERMEABLE, IN THAT THEY ALLOW OXYGEN TO PASS THROUGH THEM, IT'S A SIMPLE THING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269225 TOTALCARE SOLUTIONS LPN ABBOTT MEDICAL OPTICS 07529X UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S