BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU WITH MOISTURELOC MULTI-PURPOSE SOLUTION

    MDR report key: 754001 · Received August 24, 2006

    Report

    Report Number
    1313525-2006-00441
    Event Type
    Injury
    Date Received
    August 24, 2006
    Report Date
    May 18, 2006
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    LPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    BAUSCH & LOMB INITIATED AN INVESTIGATION THAT EVALUATED THE MFG FACILITY ENVIRONMENTAL RECORDS, A REVIEW OF BATCH RECORDS AND TESTING OF RETAIN SAMPLES FOR NUMEROUS PRODUCED LOTS. ALL OF THE RECORDS INDICATE, THERE WERE NO ANOMALIES THAT COULD HAVE BEEN RELATED TO THE REPORT, THERE WERE NO FUSARIUM RECOVERIES FROM THE FACILITY ENVIRONMENTAL MONITORING PROGRAM OF THE ASEPTIC PROCESSING AREAS, AND ALL PRODUCT RELEASE STERILITY EVALUATIONS MET CRITERIA. PRODUCT RETAIN SAMPLE TESTING WAS COMPLETED WHERE LOT NUMBERS WERE AVAILABLE AND INDICATED THAT ALL CHEMICAL AND BIOCIDAL PERFORMANCE WAS EFFECTIVE AGAINST MICROBIAL CHALLENGES AS REQUIRED. THE CONCLUSION OF THIS INVESTIGATION IS THAT SOME ASPECT OF THE MOISTURELOC FORMULA MAY BE INCREASING THE RELATIVE RISK OF FUNGAL KERATITIS IN UNUSUAL CIRCUMSTANCES. WE ARE CONTINUING TO INVESTIGATE THIS LINK BUT IN THE MEANTIME, WE ARE TAKING THE MOST RESPONSIBLE ACTION IN THE INTEREST OF OUR CUSTOMERS BY DISCONTINUING THE MOISTURELOC FORMULA AND RECALLING ALL DISTRIBUTED PRODUCT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED VIA LEGAL SUMMONS THAT A FEMALE PT DEVELOPED A FUNGAL EYE INFECTION AFTER USING RENU WITH MOISTURELOC MULTI-PURPOSE SOLUTION. BECAUSE OF HER CONDITION, THE PT SUFFERED EYE PAIN, VISION LIMITATIONS, LOSS OF VISION, EYE REDNESS, TEARIN , DISCHARGE, SENSITIVITY TO LIGHT, HEADACHES AND CORNEAL INFLAMMATION/ULCERATION/INJURY. THE PT WAS TREATED WITH AN UNSPECIFIED ANTIFUNGAL MEDICATION. THE EYE INFECTION PERSISTS AND CONTINUES TO CAUSE INJURY. IT WAS NOTED THAT THE PT MIGHT REQUIRE MONITORING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention