BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREQUENCY 55 TORIC (METHAFILCON B)

    MDR report key: 2552589 · Received April 25, 2012

    Report

    Report Number
    1314956-2012-00006
    Event Type
    Injury
    Date Received
    April 25, 2012
    Report Date
    March 26, 2012
    Manufacturer
    COOPERVISION, INC.
    Product Code
    LPL
    PMA / PMN Number
    K962185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING FILED AS AN UNCONFIRMED EYE INFECTION. METHOD: NO LOT INFO, NO LENSES, NO DEVICE INFO, NO EXAMINATION OF DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. RESULTS: WE ARE REPORTING THIS BECAUSE WE CANNOT CONFIRM THAT THERE WAS NO PERMANENT IMPAIRMENT OR PERMANENT DAMAGE. THERE IS NO CLEAR INDICATION THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. SHOULD ADD'L INFO BE RECEIVED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE FILED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE DOCTOR CALLED IN TO LEAVE A MESSAGE REGARDING HIS PT, WHO HAD SLEPT IN THE LENSES AND DEVELOPED AN EYE INFECTION. THE DOCTOR SPECULATED THAT THE PT MAY NEED A CORNEAL TRANSPLANT AS A RESULT OF THE INFECTION. NO LOT NUMBERS WERE PROVIDED. F/U ATTEMPTS HAVE BEEN MADE WITH THE REPORTING DOCTOR, WITH NO REPLY TO DATE. THIS IS BEING FILED AS AN UNCONFIRMED EYE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREQUENCY 55 TORIC (METHAFILCON B) LPL, SOFT CONTACT, DAILY WEAR LPL COOPERVISION, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other