BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMFILCON A/BIOFINITY SPHERE

    MDR report key: 4002176 · Received July 25, 2014

    Report

    Report Number
    2640128-2014-00009
    Event Type
    Injury
    Date Received
    July 25, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 2, 2014
    Manufacturer
    COOPER VISION CARRIBBEAN CORP
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LENSES WERE NOT RETURNED. THE COMPLAINT IS UNCONFIRMED. THE ASSOCIATION BETWEEN COOPERVISION LENSES AND THE INCIDENT IS UNCONFIRMED.

    Description of Event or Problem · 1

    INITIAL REPORT RELATED BY THE EYE CARE PRACTITIONER (ECP) THAT A PT WAS SEEN ON (B)(6) 2014 FOR A "WHITE SPOT" OD. THIS WAS FIRST NOTICED BY ANOTHER PROVIDER ABOUT ONE WEEK PRIOR WHEN ORAL CIPROFLOXACIN AND NEOMYCIN EYE DROPS WERE PRESCRIBED. FOLLOW UP VISIT TO THE ECP FOR C/O WHITE SPOT REMAINING AND THAT EYELIDS HAVE BEEN ITCHY AND SWOLLEN. THE ECP NOTES THAT THIS IS RELATED TO CONTACT LENS OVER WEAR OF TRIAL LENSES FOR TWO MONTHS. EXAM FOR THE RIGHT EYE RELATES MODERATE EPITHELIAL STAINING, MILD EPITHELIAL EDEMA, TRACE STROMAL EDEMA, TRACE LIMBAL AND BULBAR INJECTION. FLUORESCEIN STAINING SHOWS RIGHT EYE SUPERIOR-TEMPORAL PARACENTRAL CORNEAL ULCER. THE LEFT EYE IS CLEAR. THE DIAGNOSIS IS CONTACT LENS RELATED KERATITIS OD. MED INTERVENTION BY MEDICAL PRESCRIPTION WAS GIVEN TO PRECLUDE PERMANENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437129 COMFILCON A/BIOFINITY SPHERE COMFLICON A/BIOFINITY SPHERE LPM COOPER VISION CARRIBBEAN CORP 11298500012011

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R