BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY MULTIFOCAL

    MDR report key: 3020595 · Received March 21, 2013

    Report

    Report Number
    9614392-2013-00013
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 21, 2013
    Manufacturer
    COOPERVISION MANUFACTURING, LTD.
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    COOPERVISION WAS MADE AWARE FROM THE (B)(6) REGARDING A PT THAT CAME IN FOR A ECP VISIT WITH PROBLEMS OF RED EYES FOR 2 WEEKS. THE PT DID NOT WEAR LENSES FOLLOWING THE INCIDENT FOR 2 WEEKS. AFTER NOT WEARING THE LENSES FOR 2 WEEKS, THE PT TRIED THE LENSES ONCE MORE AND EXPERIENCED RED EYES, LIGHT SENSITIVITY AND DISCOMFORT. THE ECP ALSO FOUND SEVERE KERATITIS AND BILATERAL CONJUNCTIVITIS. THE ECP ADVISED THE PT TO STOP WEARING THE LENSES AND REFERRED THE PT TO AN EYE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117440 BIOFINITY MULTIFOCAL LPM, SOFT CONTACT LENS, EXTENDED WEAR LPM COOPERVISION MANUFACTURING, LTD. 10598000008503

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization