BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU MULTI-PURPOSE SOLUTION

    MDR report key: 806836 · Received January 18, 2007

    Report

    Report Number
    1313525-2007-00023
    Event Type
    Injury
    Date Received
    January 18, 2007
    Report Date
    April 14, 2006
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    LPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAUSCH & LOMB IS UNABLE TO COMPLETE AN INVESTIGATION OF THIS COMPLAINT SINCE NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. HOWEVER, THE COMPANY DID INITIATE A BROADER INVESTIGATION OF REPORTED FUSARIUM KERATITIS EVENTS THAT EVALUATED THE MANUFACTURING FACILITY ENVIRONMENTAL RECORDS, A REVIEW OF BATCH RECORDS AND TESTING OF RETAIN SAMPLES FOR NUMEROUS PRODUCED PRODUCT LOTS. ALL OF THE RECORDS INDICATE THERE WERE NO ANOMALIES THAT COULD HAVE BEEN RELATED TO REPORTED FUSARIUM KERATITIS, THERE WERE NO FUSARIUM RECOVERIES FROM THE FACILITY ENVIRONMENTAL MONITORING PROGRAM OF THE ASEPTIC PROCESSING AREAS, AND ALL PRODUCTS EVALUATED MET RELEASE STERILITY CRITERIA. WHERE PRODUCT RETAIN SAMPLE TESTING WAS COMPLETED ALL CHEMICAL AND BIOCIDAL PERFORMANCE CRITERIA WERE EFFECTIVE AGAINST MICROBIAL CHALLENGES AS REQUIRED.

    Description of Event or Problem · 1

    TELEPHONE CALL WAS RECEIVED FROM CONSUMER REPORTING SHE BELIEVED SHE HAD A CASE OF FUSARIUM INFECTION. CONSUMER REPORTED SHE WAS TREATED AT AN URGENT CARE CENTER AND WAS PRESCRIBED (UNSPECIFIED) ANTIBIOTIC EYE DROPS. AFTER SEVERAL CONTACTS WITH CONSUMER , SIGNED HEALTH INFORMATION AUTHORIZATION RECEIVED (LIMITING RECORDS TO BE RELEASED FROM JUNE 2005 TO JUNE 2006) AND SENT TO HEALTH SYSTEM CONSUMER IDENTIFIED-HEALTH SYSTEM RESPONDED NO MEDICAL RECORDS AFTER LAST SEEN IN JANUARY 2004. UNABLE TO OBTAIN MEDICAL RECORDS TO VERIFY REPORTED CASE OF FUSARIUM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention