BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY SPHERE (COMFILCON A)

    MDR report key: 2121037 · Received June 9, 2011

    Report

    Report Number
    9614392-2011-00033
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 19, 2011
    Manufacturer
    COOPERVISION MANUFACTURING, LTD.
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT WAS RECEIVED FROM EYE CARE PRACTITIONER TO COOPERVISION (B)(4). PT WAS A WALK-IN AND REFERRED TO A SPECIALIST. NO ADDITIONAL INFO HAS BEEN RECEIVED. 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: 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 ADDITIONAL INFO.

    Description of Event or Problem · 1

    PT WAS A WALK-IN OF A PRACTICE. PT DOES NOT TYPICALLY SLEEP IN LENSES, BUT SLEPT IN THEM FOR TWO NIGHTS AND CAME INTO THE EYE CARE PRACTITIONERS OFFICE AND WAS DIAGNOSED WITH A CORNEAL ULCER IN HER LEFT EYE ON (B)(6), 2011. PT WAS REFERRED ONTO A SPECIALIST. NO ADDITIONAL INFO HAS BEEN RECEIVED DESPITE SEVERAL REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOFINITY SPHERE (COMFILCON A) LPM, SOFT CONTACT LENS, EXTENDED WEAR LPM COOPERVISION MANUFACTURING, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other