BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU (UNK TYPE)

    MDR report key: 789950 · Received December 1, 2006

    Report

    Report Number
    1313525-2006-00602
    Event Type
    Injury
    Date Received
    December 1, 2006
    Report Date
    July 31, 2006
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    LPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    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 CO 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 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

    AN ATTORNEY REPORTED THAT AS A RESULT OF USING AN UNSPECIFIED RENU SOLUTION, A MALE PT SUSTAINED PERSONAL INJURIES INCLUDING, BUT NOT LIMITED TO LOSS OF VISION. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention