BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY TORIC (COMFILCON A)

    MDR report key: 3873170 · Received June 13, 2014

    Report

    Report Number
    9614392-2014-00011
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 20, 2014
    Manufacturer
    COOPERVISION MANUFACTURING, LTD
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LENSES WERE NOT RETURNED. LOT NUMBERS ARE UNKNOWN. THE COMPLAINT IS UNCONFIRMED. THE ASSOCIATION BETWEEN COOPERVISION LENSES AND THE INCIDENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    PATIENT WAS WEARING THE LENSES IN A POOL AND HAD OPENED EYES OPEN UNDER WATER. THE LENS STARTED TO "GALL" IN THE EYE THAT SAME EVENING, SO THE PATIENT REMOVED THE LENS. THE PATIENT WOKE THE NEXT DAY WITH VERY RED EYE, PAIN AND LIGHT SENSITIVITY. THE PATIENT CLAIMS TO HAVE SOUGHT EMERGENCY CARE ON (B)(6) 2014. THE PATIENT WAS SEEN ON (B)(6) 2014 BY AN OPTICIAN WHO DESCRIBED RIGHT EYE MODERATE CORNEAL INFILTRATES, SEVERE LIMBAL AND BULBAR INJECTION, MODERATE SUPERFICIAL ENDOTHELIUM DAMAGE, MODERATE PERIPHERAL CORNEAL SCAR OR OPACITY AND A TEMPORARY DECREASE IN VISUAL ACUITY. THE OPTICIAN RELATED A CONCLUSION OF A CORNEAL INFECTION WITH TREATMENT. THE TYPE OF TREATMENT IS UNKNOWN. FOLLOW- UP INFORMATION TO CLARIFY WAS ATTEMPTED BUT NO FURTHER INFORMATION WAS RECEIVED AS OF THIS REPORT. CONTACT LENS REST WAS PRESCRIBED. LOT NUMBERS ARE UNKNOWN. LENSES WERE NOT RETURNED FOR INSPECTION. THE COMPLAINT IS UNCONFIRMED. THE EVENT IS BEING REPORTED ON THE REPORT OF INFECTION WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350870 BIOFINITY TORIC (COMFILCON A) LENSES, SOFT CONTACT, EXTENDED WEAR LPM COOPERVISION MANUFACTURING, LTD UKN

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| R