BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLEAR TORIC XR (OMAFILCON A)

    MDR report key: 2443971 · Received February 7, 2012

    Report

    Report Number
    1314956-2012-00001
    Event Type
    Injury
    Date Received
    February 7, 2012
    Report Date
    February 1, 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 CORNEAL ULCER AND REDUCED VISUAL ACUITY LASTING LONGER THAN 7 DAYS. 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 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

    ON (B)(6) 2011, IT WAS REPORTED THAT THE PT HAD CORNEAL ABRASIONS. THIS TYPICALLY IS NOT REPORTABLE, HOWEVER, SEVERAL ATTEMPTS TO F/U WITH THE PT AND THE ECP RESULTED IN A RESPONSE ON (B)(6) 2012 NOTES ON THE MEDICAL INCIDENT REPORT, CORNEAL ULCER AND REDUCTION OF VISUAL ACUITY LASTING LONGER THAN 7 DAYS. ALONG WITH GPC AND KERATITIS.

    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