BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRASOFT XW TORIC (METHAFILCON B)

    MDR report key: 2447480 · Received February 9, 2012

    Report

    Report Number
    1314956-2012-00002
    Event Type
    Injury
    Date Received
    February 9, 2012
    Report Date
    January 19, 2012
    Manufacturer
    COOPERVISION, INC.
    Product Code
    LPM
    PMA / PMN Number
    P850079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING FILED AS UNCONFIRMED EYE INFECTION. METHOD: NO LENSES, NO EXAMINATION OF DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. RESULTS: THERE IS NO CLEAR INDICATION THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. CONCLUSIONS: THERE IS NOT SUFFICIENT INFORMATION PROVIDED TO DRAW A CONCLUSIONS AS TO WHETHER OR NOT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE PT'S COMPLAINT. NO CONCLUSION CAN BE DRAWN. SHOULD FURTHER INFORMATION BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN ONE MONTH OF RECEIPT OF THE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    ACCOUNT CALLED WANTING TO KNOW HOW TO DISINFECT A LENS THAT HAD PREVIOUSLY BEEN WORN WHILE THE PT HAD AN EYE INFECTION, TO PREVENT RE-INFECTION. FOLLOW UP WITH THE ACCOUNT FOR MORE INFORMATION WAS MADE WITH NO REPLY TO DATE. THIS IS BEING FILED AS UNCONFIRMED EYE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRASOFT XW TORIC (METHAFILCON B) LPM, SOFT CONTACT LENS, EXTENDED WEAR LPM COOPERVISION, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other