BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY SPHERE (COMFILCON A)

    MDR report key: 2121039 · Received June 9, 2011

    Report

    Report Number
    9614392-2011-00031
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 19, 2011
    Manufacturer
    COOPERVISION MANUFACTURING LIMITED
    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). METHOD: NO LOT INFORMATION, NO LENSES, NO DEVICE INFORMATION, 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 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

    PT HAS BEEN WEARING BIOFINITY LENSES SINCE (B)(6) 2009 WITH NO PRIOR INCIDENTS. ON (B)(6), 2011, THE PT WAS DISPENSED BIOFINITY SPHERE LENSES. PT SUFFERED PAIN IN THE LEFT EYE ALONG WITH THE EYE BEING WATERY AND RED. PT WAS DIAGNOSED ON (B)(6), 2011 WITH A CORNEAL ULCER. PT USES OPTI-FREE/RENU MULTIPURPOSE SOLUTION AND WAS WEARING THE LENSES ON A CONTINUOUS WEAR BASIS (29 NIGHTS). PT WAS PRESCRIBED VIGAMOX, CILOXAN AND FML EYE DROPS. PT TEMPORARILY DISCONTINUED LENS WEAR AND HAS MADE A FULL RECOVERY. PT HAS BEEN ADVISED TO REMOVE LENSES AT NIGHT.

    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 LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other