BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU MULTIPLUS MULTI-PURPOSE SOLUTION

    MDR report key: 1673749 · Received April 29, 2010

    Report

    Report Number
    1313525-2010-00003
    Event Type
    Injury
    Date Received
    April 29, 2010
    Date of Event
    September 10, 2009
    Report Date
    March 31, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    LYL
    PMA / PMN Number
    K020802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND EVALUATION RESULTS FOUND THE SOLUTION MET ALL SPECIFICATIONS FOR PH, TONICITY, COLOR, AND CLARITY. A REVIEW OF THE LOT BATCH RECORDS AND CHEMICAL TESTING OF THE RETAIN SAMPLE SHOWED ALL REQUIREMENTS WERE MET. MEDICAL DOCUMENTATION DOES NOT DIRECTLY RELATE EVENT TO A SPECIFIC PRODUCT OR CAUSE. BASED ON ALL INFORMATION, NO CAUSAL FACTOR CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PATIENT'S FATHER REPORTED DAUGHTER WAS DIAGNOSED WITH A FUNGAL EYE INFECTION IN LEFT EYE. FOLLOW-UP WITH THE TREATING DOCTORS CONFIRMED THE PATIENT WAS FIRST DIAGNOSED WITH A CORNEAL ULCER AND TREATED WITH ANTIBIOTICS. AFTER ALMOST TWO MONTHS WITH NOT MUCH IMPROVEMENT, PATIENT WAS REFERRED TO A CORNEAL SPECIALIST. THE SPECIALIST DIAGNOSED A FUNGAL CORNEAL ULCER BASED ON THE PATIENT'S PRESENTATION, EXAM, AND RESPONSE. ALL WERE CLASSIC FOR FUNGAL KERATITIS EVEN THOUGH THE CULTURES WERE NEGATIVE. PATIENT HAD A "CRYSTALLINE KERATOPATHY." PATIENT RECOVERED WITH CORNEAL SCAR. VISION IS 20/20 WITH EYE GLASS CORRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENU MULTIPLUS MULTI-PURPOSE SOLUTION LYL BAUSCH & LOMB GK8014

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention TWO-WEEK DISPOSABLE LENSES (BRAND TYPE UNKNOWN)