BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU (UNKNOWN TYPE)

    MDR report key: 776747 · Received November 3, 2006

    Report

    Report Number
    1313525-2006-00537
    Event Type
    Injury
    Date Received
    November 3, 2006
    Report Date
    June 6, 2006
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    LPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 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 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 REPORT WAS REC'D FROM AN ATTORNEY STATING THAT A MALE PT SUFFERED PERMANENT AND IRREVERSIBLE INJUIRIES AND DAMAGES WHILE USING RENU SALINE SOLUTION. IT WAS SPECIFICALLY NOTED THAT PT EXPERIENCED INJURIES WHICH INCLUDED, BUT NOT LIMITED TO COMPLETE BLINDNESS.

    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| S