BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IWEAR XR SUPREME (COMFILCON A)

    MDR report key: 2200860 · Received August 8, 2011

    Report

    Report Number
    9614392-2011-00044
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 30, 2011
    Manufacturer
    COOPERVISION MANUFACTURING LIMITED
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS REPORTED BY THE EYE CARE PROFESSIONAL TO COOPERVISION'S SALES REPRESENTATIVE IN (B)(4). METHOD: THERE IS NO EVIDENCE IN THE MANUFACTURING RECORDS WHICH RELATE TO THE PATIENT'S SYMPTOMS. RESULTS: THERE IS NO CLEAR INDICATION THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. THIS IS BEING REPORTED AS A CORNEAL ULCER TREATED WITH MEDICATION. WE ARE REPORTING THIS BECAUSE WE CANNOT RULE OUT THAT OUR PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT AS REPORTED BY THE PATIENT. 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

    PATIENT IS AN EXISTING CONTACT LENS WEARER. IN (B)(6), 2011, PATIENT WAS DISPENSED IWEAR XR SUPREME (COMFILCON A) SOFT CONTACT LENSES. ON THE EVENING OF (B)(6), 2011, THE PATIENT STRUGGLED TO REMOVE THE LENS FROM THE EYE. PATIENT EXPERIENCED DISCOMFORT DURING THE NIGHT AND THE NEXT MORNING THE EYE WAS RED. ON (B)(6), 2011, PATIENT WAS DIAGNOSED WITH FOREIGN BODIES ON THE EYE AND DUE TO SEVERE REDNESS, THE OPTICIAN ADVISED THE PATIENT TO ATTEND THE CLINIC. THE CLINIC DIAGNOSED A CORNEAL ULCER IN THE LEFT EYE. PATIENT WAS USING ALL-IN-ONE SUPREME CLEANING SOLUTION. PATIENT WAS TREATED WITH GENTAMICIN EYE DROPS AND HAS BEEN ADVISED TO TEMPORARILY DISCONTINUE USE OF CONTACT LENS WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IWEAR XR SUPREME (COMFILCON A) LPM, SOFT CONTACT LENS, EXTENDED WEAR LPM COOPERVISION MANUFACTURING LIMITED 4450554707

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other