BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY SPHERE (COMFILCON A)

    MDR report key: 2011566 · Received March 7, 2011

    Report

    Report Number
    9614392-2011-00007
    Event Type
    Injury
    Date Received
    March 7, 2011
    Report Date
    February 8, 2011
    Manufacturer
    COOPERVISION MANUFACTURING LIMITED
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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: WE ARE REPORTING THIS BECAUSE WE CANNOT CONFIRM THAT THERE WAS NO PERMANENT IMPAIRMENT OR PERMANENT DAMAGE. THERE IS NO CLEAR INDICATION THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. 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 ADD'L INFO.

    Description of Event or Problem · 1

    ON (B)(6) 2011, COOPERVISION REC'D A CALL FROM A PRACTICE REGARDING A PT WHO ATTENDED A HOSPITAL AND HAD BEEN DIAGNOSED WITH A CORNEAL ULCER, STATING THE LENSES WERE THE CAUSE. THE ORIGINAL LENSES WERE DESTROYED, AND THE PRACTICE REQUESTED THE REMAINING LENSES FROM THE PT. AS OF (B)(6) 2011, THE PRACTICE HAD NOT REC'D ANY OTHER FORM OF COMMUNICATION FROM THE PT OR THE TREATING HEALTH CARE PROFESSIONAL. THEY WERE UNABLE TO CONFIRM THE DIAGNOSIS OF A CORNEAL ULCER AS THEY DID NOT TREAT THE PT.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other