BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU WITH MOISTURELOC MULTI-PURPOSE SOLUTION

    MDR report key: 651480 · Received December 8, 2005

    Report

    Report Number
    1313525-2005-00039
    Event Type
    Injury
    Date Received
    December 8, 2005
    Date of Event
    January 1, 2005
    Report Date
    November 13, 2005
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    LYL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEPARTMENT OF HEALTH OVERSEAS REPORTED A RISING TREND IN CONTACT LENS (CL) RELATED KERATITIS. ACCORDING TO HOSPITAL RECORDS, A RISING TREND FOR HOSPITAL ADMISSION DUE TO CL RELATED KERATITIS WAS OBSERVED IN 2005. A TOTAL OF 68 EPISODES OF CL RELATED KERATITIS (40.5% OF ALL ADMISSION EPISODES DUE TO "ALL KERATITIS" IN THE SAME PERIOD) WERE RETRIEVED FROM IN PATIENT RECORDS. OUT OF THE 68 EPISODES BETWEEN JUNE AND SEPTEMBER 2005, 2 PATIENTS HAD BEEN ADMITTED TWICE FOR CL RELATED KERATITIS DURING THE SAME PERIOD. THUS 66 PATIENTS WERE IDENTIFIED. SIXTY-TWO PATIENTS WERE INTERVIEWED FOR FURTHER INFORMATION ABOUT THE CONTACT LENS SOLUTION AND CONTACT LENS THEY USED. AMONG THE 62 PATIENTS, 25 REPORTED TO HAVE USED BAUSCH & LOMB RENU CONTACT LENS SOLUTION BEFORE THEIR SYMPTOM ONSET. AMONG 25 USERS, FUSARIUM SPP. WAS MORE COMMONLY ISOLATED FROM THE CLINICAL SPECIMENS (7 OUT OF 20 SPECIMENS). ONLY A FEW PATIENTS COULD PROVIDE THE LOT NUMBERS OF THE CONTACT LENS SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU WITH MOISTURELOC MULTI-PURPOSE SOLUTION MULTI-PURPOSE SOLUTION FOR SOFT CONTACT LENSES LYL BAUSCH & LOMB, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R