BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU FRESH MULTI-PURPOSE SOLUTION

    MDR report key: 2565449 · Received April 30, 2012

    Report

    Report Number
    1313525-2012-00012
    Event Type
    Injury
    Date Received
    April 30, 2012
    Report Date
    April 26, 2012
    Manufacturer
    BAUSCH + LOMB
    Product Code
    LYL
    PMA / PMN Number
    K020802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNK. THE ARTICLE DOES NOT RELATE THE EVENT TO A SPECIFIC PRODUCT BUT DOES REFERENCE THE NEED FOR MORE DETAILED INFORMATION TO BE PROVIDED TO CONTACT LENS USERS CONCERNING THE PREVENTION AND MANAGEMENT OF POTENTIAL COMPLICATIONS. BASED ON ALL INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    LITERATURE ARTICLE STATED PT PRESENTED TO THE EMERGENCY DEPARTMENT COMPLAINING OF PAIN AND REDNESS IN BOTH EYES. SLIT LAMP EXAMINATION REVEALED TWO INFILTRATES IN THE INFERIOR PART OF THE CORNEA IN THE RIGHT EYE AND FIVE SMALLER INFILTRATES IN THE SUPERIOR HALF OF THE LEFT CORNEA. PT WAS HOSPITALIZED FOR TWO DAYS DUE TO HER ANXIETY OF TREATING HERSELF AT HOME. SYMPTOMS IMPROVED AFTER HOSPITALIZATION AND TREATMENT. AT FINAL FOLLOW UP VISIT ONE WEEK LATER, PT'S CONDITION RESOLVED. A CULTURE OF THE CONTACT LENS REVEALED SERRATIA MARCESCENS AS THE RESPONSIBLE INFECTIOUS FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU FRESH MULTI-PURPOSE SOLUTION LYL BAUSCH + LOMB

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R