BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUVUE OASYS

    MDR report key: 2163533 · Received July 7, 2011

    Report

    Report Number
    MW5021303
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    VISTAKON (J&J)
    Product Code
    LPL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TKC SECONDARY TO CL WEAR. FREQUENCY: DAILY, LENS AND SOLUTION QHA. DATES OF USE: 2 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUVUE OASYS NONE LPL VISTAKON (J&J)
    2 OPTI-FREE REPLENISH NONE LPN ALCON

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Disability