BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU WITH MOISTURELOC MULTI-PURPOSE SOLUTION

    MDR report key: 774356 · Received October 30, 2006

    Report

    Report Number
    1313525-2006-00268
    Event Type
    Injury
    Date Received
    October 30, 2006
    Date of Event
    November 1, 2005
    Report Date
    May 17, 2006
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    LPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BAUSCH & LOMB INITIATED AN INVESTIGATION THAT EVALUATED THE MANUFACTURING FACILITY ENVIRONMENTAL RECORDS, A REVIEW OF BATCH RECORDS AND TESTING OF RETAIN SAMPLES FOR NUMEROUIS PRODUCED LOTS. ALL OF THE RECORDS INDICATE THERE WERE NO ANOMALIES THAT COULD HAVE BEEN RELATED TO THE REPORT, THERE WERE NO FUSARIUM RECOVERIES FROM THE FACILITY ENVIRONMENTAL MONITORING PROGRAM OF THE ASEPTIC PROCESSING AREAS, AND ALL PRODUCT RELEASE STERILITY EVALUATIONS MET CRITERIA. PRODUCT RETAIN SAMPLE TESTING WAS COMPLETED WHERE LOT NUMBERS WERE AVAILABLE AND INDICATED THAT ALL CHEMICAL AND BIOCIDAL PERFORMANCE WAS EFFECTIVE AGAINST MICROBIAL CHALLENGES AS REQUIRED. THE CONCLUSION OF THIS INVESTIGATION IS THAT SOME ASPECT OF THE MOISTURELOC FORMULA MAY BE INCREASING THE RELATIVE RISK OF FUSARIUM KERATITIS IN UNUSUAL CIRCUMSTANCES. WE ARE CONTINUING TO INVESTIGATE THIS LINK, BUT IN THE MEANTIME, WE ARE TAKING THE MOST RESPONSIBLE ACTION IN THE INTEREST OF OUR CUSTOMERS BY DISCONTINUING THE MOISTURELOC FORMULA AND RECALLING ALL DISTRIBUTED PRODUCT.

    Description of Event or Problem · 1

    A PHONE CALL WAS RECEIVED FROM A DOCTOR AT HOSPITAL IN ANOTHER COUNTRY. HE REPORTS THAT IN 2005, A FEMALE DEVELOPED AN ABSCESS UNDER HER COLORED CONTACT LENS WHICH WAS TREATED WITH CORTICOIDS. AFTER 12 DAYS, CONSUMER WAS TREATED FOR HYPOPION, TYNDALL, ABSCESSES WITH AMPHOTERICINB AND ITRACONAZOLE. SEVEN DAYS LATER, AGGRAVATION WITH SEVERE CORNEAL MELTING AND PERFORATION OCCURRED WITH SUBSEQUENT 30 DAY HOSPITALIZATION. TREATMENT WITH NATAMYCIN AND VORICONAZOLE. THE ULCER HEALED IN 20 DAYS, CONJUNTIVAL COVERING AT 17 DAYS AND 27 DAYS. VISUAL ACUITY LIMITED TO MOVEMENT PERCEPTION AT 2 MONTHS. A GRAFT IS IMPOSSIBLE DUE TO SURFACE OF THE LESION. FUSARIUM IDENTIFIED IN THE CONTACT LENS CASE. THE DOCTOR REPORTS THAT THE CONSUMER HAD POOR HYGEINIC PRACTICES. THE CONSUMER IS NEAR BLINDNESS. NO FURTHER INFORMATION OR ANY MEDICAL DOCUMENTATION AVAILABLE.

    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 LPN BAUSCH & LOMB, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention