BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREVISION TORIC (BALAFILCON A) CONTACT LENS

    MDR report key: 1111032 · Received August 12, 2008

    Report

    Report Number
    1313525-2008-00027
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    June 3, 2008
    Report Date
    July 24, 2008
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LPM
    PMA / PMN Number
    P980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTACT LENS WAS EVALUATED AND WAS FOUND TO BE WITHIN SPECIFICATION. THE LOT DEVICE HISTORY RECORDS WERE REVIEWED AND SHOW THAT ALL REQUIREMENTS WERE MET. BASED ON THE INFO, NO ROOT CAUSE CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PT PRESENTED WITH REDNESS IN BOTH EYES. UPON EXAMINATION, THE CONJUNCTIVAE WERE RED, THE VESSELS ON THE EDGE OF THE CORNEA WERE EXTENDED AND SHOWED A GROWTH TREND ON THE CORNEA. THE CORNEA HAD SMALL SPOTS AND CORNEAL OPACITY. THE OPACITY WAS LOCATED IN THE CENTRAL 4MM OF THE CORNEA. THERE WAS NO PERMANENT DECREASE IN THE PT'S VISUAL ACUITY. THE BLOOD VESSELS DID NOT EXTEND INTO THE VISUAL AXIS. DR REPORTED FOLLOWING THERAPY AND TEMPORARY DISCONTINUANCE OF LENS WEAR, THE PT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUREVISION TORIC (BALAFILCON A) CONTACT LENS 86LPM LPM BAUSCH & LOMB Y88401326

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention