BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU WITH MOISTURELOC MULTI-PURPOSE SOLUTION

    MDR report key: 755394 · Received August 25, 2006

    Report

    Report Number
    1313525-2006-00401
    Event Type
    Injury
    Date Received
    August 25, 2006
    Date of Event
    April 10, 2006
    Report Date
    April 13, 2006
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    LPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CHEMICAL TESTING OF THE RETURNED SAMPLE SHOWED THE PRODUCT MET ALL SHELF LIFE LIMITS. BAUSCH & LOMB INITIATED AN INVESTIGATION THAT EVALUATED THE MANUFACTURING FACILITY ENVIRONMENTAL RECORDS, A REVIEW OF BATCH RECORDS AND TESTING OF RETAIN SAMPLES FOR NUMEROUS 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 MOTHER REPORTED THAT HER DAUGHTER EXPERIENCED SYMPTOMS OF AN INFECTED RIGHT EYE, WHICH SHE BELIEVED WAS FUSARIUM KERATITIS WHILE USING RENU WITH MOISTURELOC MULIT-PURPOSE SOLUTION. THE MOTHER REPORTED THAT HER DAUGHTER USED THIS PARTICULAR BOTTLE (LOT # GH5114) FOR APPROXIMATELY ONE MONTH. IN 2006, THE DAUGHTER WAS EXAMINED BY A PHYSICIAN WHO DIAGNOSED HER WITH AN EYE INFECTION OF THE RIGHT EYE. THE PHYSICIAN HAD CULTURES PERFORMED AND ALSO PRESCRIBED A MEDICATION (DRUG NAME UNKNOWN) TO TREAT THE DAUGHTER'S INFECTION. THE CULTURE RESULTS ARE UNKNOWN. ALTHOUGH FURTHER INFORMATION WAS REQUESTED MULTIPLE TIMES, THE TREATING PHYSICIAN DECLINED TO PROVIDE FURTHER DETAILS.

    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 GH5114

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention
    2