BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENUE (UNKNOWN TYPE)

    MDR report key: 765340 · Received September 27, 2006

    Report

    Report Number
    1313525-2006-00476
    Event Type
    Injury
    Date Received
    September 27, 2006
    Date of Event
    August 6, 2004
    Report Date
    July 24, 2006
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    LPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 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 MALE PATIENT REPORTED EXPERIENCING AN EYE INFECTION WHILE USING RENU (UNKNOWN TYPE). BASED ON MEDICAL RECORDS RECEIVED, IN 2004, THE PATIENT PRESENTED TO AN EMERGENCY ROOM AND WAS INSTILLED AN UNSPECIFIED ANTIBIOTIC FOR INFECTION IN BOTH EYES (OU) AND RIGHT LID LESION. THE PATIENT WAS REFERRED TO AND SEEN LATER THAT DAY BY AN OPHTHALMOLOGIST. THE OPHTHALMOLOGIST REPORTED THE PATIENT PRESENTED WITH ALLERGIC-TYPE SYMPTOMS OF EYE REDNESS, TEARING, AND EYE PAIN, WHICH HAD BEGUN THREE DAYS PRIOR. THE PATIENT WAS DIAGNOSED WITH ADVANCED CORNEAL ULCERS OU. HE WAS PRESCRIBED VIGAMOX AND DOXYCYCLINE. DOXYCYCLINE WAS DISCONTINUED THE FOLLOWING DAY. ON SUCCEEDING FOLLOW-UP VISIT, INFILTRATES OD AND A SCAR OU WERE NOTED. DURING 2004, THE PATIENT WAS SEEN BY ANOTHER EYE SPECIALIST WHO CONFIRMED A DIAGNOSIS OF CORNEAL ULCERS OU. THE RIGHT EYE ULCER WAS LOCATED IN THE CENTRAL 4 MM OF THE CORNEA, WHILE THE ULCER IN THE LEFT EYE WAS NOT. NO CULTURE WAS PERFORMED. PRIOR TO THAT YEAR, SYMPTOMS HAD IMPROVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention COUMADIN| DEMEROL| ZOCOR| ALLOPURINOL| TOPROL| ACUVUE II CONTACT LENSES