BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY (COMFILCON A)

    MDR report key: 2050877 · Received April 1, 2011

    Report

    Report Number
    9614392-2011-00014
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    January 21, 2011
    Report Date
    March 7, 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

    METHOD: NO LENSES, NO DEVICE INFO, NO EXAMINATION OF DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT. THERE IS NO EVIDENCE IN THE MFG RECORDS WHICH RELATE TO THE PT'S SYMPTOMS. EVAL RESULTS: THERE IS NO DIRECT CAUSAL RELATIONSHIP ESTABLISHED BETWEEN THE MEDICAL DEVICE AND THE INCIDENT THE PT COMPLAINS OF. CONCLUSION: 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 HAD SUFFERED AN INFECTIOUS ABSCESS OF THE CORNEA IN THE RIGHT EYE WHICH WAS DIAGNOSED ON (B)(6), 2011. THE PT WAS WEARING BIOFINITY SPHERE (COMFILCON A) LENSES WHILE USING OPTIFREE SOLUTION. THE SYMPTOMS WERE CAUSED BY SAWDUST, WHICH ENTERED THE EYE WHILE THE PT WAS CUTTING WOOD. THE PT IS RECOVERING FROM HIS SYMPTOMS. NO CULTURES WERE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOFINITY (COMFILCON A) LPM, SOFT CONTACT LENS, EXTENDED WEAR LPM COOPERVISION MANUFACTURING LIMITED 6133557123

    Patients

    Seq Age Sex Outcome Treatment
    1 Other