BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU (UNKNOWN TYPE)

    MDR report key: 781386 · Received November 13, 2006

    Report

    Report Number
    1313525-2006-00553
    Event Type
    Injury
    Date Received
    November 13, 2006
    Date of Event
    June 29, 2005
    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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BAUSH & 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 ASEPTIC PROCESSING AREAS, AND ALL PRODUCT 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

    A OPTHALMOLOGIST REPORTED THAT A FEMALE PT DEVELOPED FUSARIUM KERATITIS IN THE RIGHT EYE WHILE USING RENU (UNKNOWN TYPE). THE INITIAL ONSET OF THE PT'S SYMPTOMS BEGAN IN 2006. THE PT WAS TREATED WITH HYSTATIN AND ORAL ANTIFUNGAL MEDICATIONS WITHOUT RESPONSE. PT SUBSEQUENTLY UNDERWENT A PENETRATING KERATOPLASTY 6-8 WEEKS AFTER ONSET. THE PT HAD GOOD POST-OPERATIVE RECOVERY. HER VISUAL ACUITY HAS RETURNED, BUT MAY BE LIMITED DUE TO PROGRESSIVE CATARACTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention