BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY TORIC COMFILCON A

    MDR report key: 2922615 · Received January 18, 2013

    Report

    Report Number
    9614392-2013-00003
    Event Type
    Injury
    Date Received
    January 18, 2013
    Report Date
    January 4, 2013
    Manufacturer
    COOPERVISION MANUFACTURING LIMITED
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL OR THE PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. (B)(4): NO PRODUCT RETURNED.

    Description of Event or Problem · 1

    COOPERVISION WAS MADE AWARE THAT THE PATIENT PUT A LENS IN HIS EYE IT FELT LIKE IT HAD STUCK. HE HAD A SEVERELY RED EYE AND WAS IN A LOT OF PAIN. HE WAS ADVISED TO SEEK MEDICAL ATTENTION, BUT HE REFUSED. IT WAS NOTED THAT THE PATIENT HAD A SEVERELY RED EYE, STAINING AND A SCAR ON THE CORNEA. THE LOCATION OF THE SCAR AND SIZE WAS NOT DESCRIBED. FURTHER ATTEMPTS TO CONTACT THE CUSTOMER WERE MADE, HOWEVER THERE WAS NO MORE INFORMATION REGARDING THIS CASE. NO LENSES WERE RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28175 BIOFINITY TORIC COMFILCON A LPM, SOFT CONTACT LENS, EXTENDED WEAR LPM COOPERVISION MANUFACTURING LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability