BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREQUENCY 55 TORIC (METHAFILCON A)

    MDR report key: 2440407 · Received January 31, 2012

    Report

    Report Number
    1314956-2011-00030
    Event Type
    Injury
    Date Received
    January 31, 2012
    Report Date
    December 29, 2011
    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 REPORTED AS RECURRING PUNCTATE CHEMICAL KERATITIS. 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 CONCLUSION AS TO WHETHER OR NOT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'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

    THE PATIENT HAD RECURRENT DIFFUSE PUNCTATE KERATITIS WITH INFLAMMATION IN BOTH EYES, ALTHOUGH NEVER AT THE SAME TIME. THE ECP NOTES THE PATIENT HAS PRE-EXISTING ISSUES THAT COULD BE CONTRIBUTING TO CHEMICAL KERATITIS INCLUDING LATANOPROST FOR TREATMENT OF GLAUCOMA, CHLORINE FROM SWIMMING AND THE PATIENT ALSO ADDS SALINE TO HIS LENSES TO APPLY THEM. THE PATIENTS CONDITION HAS CLEARED UP AND HAS NOT RETURNED TO THE OFFICE FOR THIS CONDITION SINCE. THE ECP FEELS THAT THIS IS CHEMICAL KERATITIS AND IS NOT RELATED TO THE LENS, HE WANTED TO ENSURE THAT THE BLISTER PACK DID NOT CONTAIN ANY PRESERVATIVES IN THE BLISTER PACK THAT COULD CONTRIBUTE TO RECURRING KERATITIS.

    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