BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREQUENCY 55 TORIC (METHAFILCON A)

    MDR report key: 2484667 · Received March 7, 2012

    Report

    Report Number
    1314956-2012-00005
    Event Type
    Injury
    Date Received
    March 7, 2012
    Report Date
    February 8, 2012
    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

    THIS IS BEING FILED AS DEEP CORNEAL ABRASION. THIS IS RELATED TO (B)(4) 1314956-2012-00004. NO LENSES, NO EXAMINATION OF DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THERE IS NO CLEAR INDICATION THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. THERE IS NOT SUFFICIENT INFORMATION PROVIDED TO DRAW A CONCLUSION AS TO WHETHER OR NOT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S COMPLAINT. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE PATIENTS MOTHER STATES HER DAUGHTER WAS TREATED FOR CORNEAL ABRASIONS IN BOTH EYES. IT WAS SUGGESTED BY THE ECP THAT IT WAS CHEMICAL IN NATURE. FOLLOW-UP WITH THE ECO NOTES THAT THE PATIENT WAS TREATED FOR DEEP CORNEAL ABRASION. THIS IS BEING FILED AS DEEP CORNEAL ABRASION.

    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 21 YR Other