BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREQUENCY 55 TORIC (METHAFILCON A)

    MDR report key: 2404259 · Received January 5, 2012

    Report

    Report Number
    1314956-2011-00025
    Event Type
    Injury
    Date Received
    January 5, 2012
    Report Date
    December 22, 2011
    Manufacturer
    COOPERVISION, INC
    Product Code
    LPM
    PMA / PMN Number
    P850079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFO PROVIDED TO DRAW A CONCLUSION AS TO WHETHER OR NOT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE PT'S COMPLAINT. 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 PT'S MOTHER REPORTS SON WAS WEARING F55T LENSES. HE CLAIMS THE LENSES WERE BLURRY AND WAS NOT ABLE TO SEE OUT OF THEM. THE PT IS NOW HAVING SURGERY AND BELIEVES IT IS DUE TO THE LENSES. SEVERAL ATTEMPTS TO F/U WITH THE PT FOR MORE INFO WAS MADE WITH NO REPLY. ON (B)(6) 2011, FURTHER REVIEW OF THE COMPLAINT DETERMINED THAT THIS EVENT IS REPORTABLE FOR LACK OF INFO AND OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREQUENCY 55 TORIC (METHAFILCON A) LPM, SOFT CONTACT LENS, EXTENDED WEAR LPM COOPERVISION, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other