BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS

    MDR report key: 1702667 · Received May 26, 2010

    Report

    Report Number
    MW5016099
    Event Type
    Injury
    Date Received
    May 26, 2010
    Date of Event
    May 26, 2010
    Report Date
    May 26, 2010
    Manufacturer
    J & J
    Product Code
    LPL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IKC SECONDARY TO CL WEAR. FREQUENCY: #1: DAILY, #2: QHS. DATES OF USE: 2 YRS. DIAGNOSIS OR REASON FOR USE: MYOPIA. EVENT ABATED AFTER USE: #1 & #2: YES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Disability