BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU MULTIPLUS

    MDR report key: 2044093 · Received April 6, 2011

    Report

    Report Number
    MW5020070
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 7, 2008
    Report Date
    December 6, 2010
    Manufacturer
    B+L
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CONTACT LENS ASSOCIATED INFILTRATIVE KERATOCONJUNCTIVITIS. MULTIPLE CORNEAL INFILTRATES WITH DECREASED VISION, REDNESS AND PAIN. DOSE OR AMOUNT: DROPS, FREQUENCY: NIGHTLY, ROUTE: TOPICAL; DOSE OR AMOUNT: CONTACT LENS, FREQUENCY: DAILY, ROUTE: TOPICAL. DATES OF USE: (B)(6) 2008. EVENT ABATED AFTER USE STOPPED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU MULTIPLUS DROPS LPN B+L
    2 ACUVUE OASYS CONTACT LENS LPL VISTAKON

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other