BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTRUE MULTI-PURPOSE SOLUTION

    MDR report key: 3067880 · Received April 11, 2013

    Report

    Report Number
    1313525-2013-00003
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    October 1, 2012
    Report Date
    April 1, 2013
    Manufacturer
    BAUSCH + LOM
    Product Code
    LYL
    PMA / PMN Number
    K083757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER INFORMATION IS UNKNOWN. DOCTOR RELATES EVENT TO THE CONTACT LENS.

    Description of Event or Problem · 1

    RECEIVED CORRESPONDENCE FROM COOPERVISION INFORMING OF A PATIENT WHO WAS DIAGNOSED WITH AN INFECTIOUS CORNEAL ULCER WHILE WEARING BIOFINITY TORIC LENS AND USING BIOTRUE MULTI-PURPOSE SOLUTION. AFTER FOUR HOURS OF WEARING THE LENS, PATIENT DEVELOPED AN UNCOMFORTABLE FEELING IN RIGHT EYE. DOCTOR DETERMINED THE INITIAL FIT TO BE ADEQUATE. WITHIN SEVERAL DAYS, THE PATIENT NOTICED A WHITE MARK ON CORNEA, CLOSE TO PUPIL, EYE WAS RED AN IRRITATED. PATIENT WAS TREATED FOR A CORNEAL INFILTRATE/ULCER WITH A TOPICAL ANTIBIOTIC AND STEROID COMBINATION DROP. AT FOLLOW UP VISIT, THE ULCER WAS 2.5MM AND HAD PENETRATED APPROXIMATELY 90% OF THE CORNEA. THE ULCER WAS CULTURED AND SERRATIA MARCESCENS WAS IDENTIFIED. AFTER MAY VISITS AND ANTIBIOTIC THERAPY, THE PROGRESSION HALTED AND THE ULCER HEALED. THE BEST VISUAL ACUITY AFTER THE EVENT WAS 20/50. PATIENT WAS EVALUATED BY A CORNEAL SPECIALIST WHO DETERMINED THE BEST CORRECTED VISUAL ACUITY IS 20/100. THE ONLY TREATMENT TO CLEAR THE PATIENT'S VISION IS A CORNEAL TRANSPLANT. DOCTOR RELATES EVENT TO THE CONTACT LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155396 BIOTRUE MULTI-PURPOSE SOLUTION LYL BAUSCH + LOM

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| R| S BIOFINITY TORIC CONTACT LENSES