BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREVISION TORIC (BALAFILCON A) CONTACT LENS

    MDR report key: 1111031 · Received August 12, 2008

    Report

    Report Number
    1313525-2008-00028
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 21, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LPM
    PMA / PMN Number
    P980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT DISCARDED THE CONTACT LENSES AND HAS NOT PROVIDED LOT NUMBER INFO OR THE NAME OF A HEALTH PROFESSIONAL TO FOLLOW UP REGARDING THE EVENT. BASED ON THE INFO, NO ROOT CAUSE CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PT REPORTS DEVELOPING AN INFECTION IN THE EYE AS A RESULT OF RETINAL ULCER AND WAS TREATED WITH VIGAMOX. PT STATES THE EYE DR INDICATED THAT IT WAS MOST LIKELY DUE TO CONTACT LENS WEAR. THE PT REPORTED WEARING THE LENSES AS CONTINUOUS WEAR AND HAD NO ADD'L INFO AT THE TIME OF THE REPORT. THE PT HAD DISCARDED THE LENSES AND HAS NOT RESPONDED TO AN ATTEMPT TO COLLECT ADD'L EVENT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUREVISION TORIC (BALAFILCON A) CONTACT LENS 86LPM LPM BAUSCH & LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OPTIFREE