BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLEAR TORIC XR (OMAFILCON A)

    MDR report key: 2483501 · Received March 5, 2012

    Report

    Report Number
    1314956-2012-00003
    Event Type
    Injury
    Date Received
    March 5, 2012
    Report Date
    February 6, 2012
    Manufacturer
    COOPERVISION, INC.
    Product Code
    LPL
    PMA / PMN Number
    K952152
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING FILED AS UNCONFIRMED INFECTION. METHOD: NO LOT INFO, NO LENSES. NO DEVICE INFO, NO EXAMINATION OF DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT. 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 EVENT. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. SHOULD FURTHER INFO BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN ONE MONTH OF RECEIPT OF THE ADD'L INFO.

    Description of Event or Problem · 1

    THE PT REPORTS THAT SHE HAS BEEN WEARING PROCLEAR TORIC XR'S FOR 5 MONTHS. MANY OF THE LENSES HAVE TORN. HALF OF A CONTACT STUCK TO THE BACK OF HER EYE FOR SEVERAL DAYS WHICH LED TO INFLAMMATION AND INFECTION. THE PT DID NOT SEEK MEDICAL TREATMENT. THE PROBLEM HAS ONLY BEEN WITH THE RIGHT EYE. FOLLOW UP WITH THE ECP NOTES THAT THEY WERE NOT AWARE OF INFECTION. THIS IS BEING FILED AS UNCONFIRMED INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCLEAR TORIC XR (OMAFILCON A) LPL, SOFT CONTACT LENS, DAILY WEAR LPL COOPERVISION, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention