BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION

    MDR report key: 9721556 · Received February 18, 2020

    Report

    Report Number
    0001313525-2020-00035
    Event Type
    Injury
    Date Received
    February 18, 2020
    Date of Event
    November 1, 2005
    Report Date
    January 21, 2020
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Product Code
    LPN
    Removal / Correction Number
    Z-1201-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT AND LOT NUMBER WERE NOT AVAILABLE. FOLLOW UP WITH THE TREATING DOCTOR INDICATED THEY HAVE NO RECORD OF THE CONSUMER USING THE PRODUCT. RENU WITH MOISTURELOC MULTI-PURPOSE SOLUTION WAS RECALLED FROM THE GLOBAL MARKET ON MAY 15, 2006. AT THAT SAME TIME, THE COMPANY DISCONTINUED THE WORLDWIDE SALES AND DISTRIBUTION OF THE DEVICE. ALSO, THE PREMARKET NOTIFICATIONS (K033854 AND K051755) FOR THE DEVICE WERE WITHDRAWN BY BAUSCH + LOMB.

    Description of Event or Problem · 1

    A CONSUMER REPORTED ABOUT FIFTEEN YEARS AGO, AFTER USING THE PRODUCT, THEY EXPERIENCED BURNING EYES, HEADACHES, LIGHT SENSITIVITY AND THEY COULD BARELY OPEN THEIR EYES. THEY VISITED THEIR EYE DOCTOR AND WAS DIAGNOSED WITH BILATERAL EYE INFECTION AND RETINA SCARRING IN THEIR LEFT EYE. THEY REPORTED AFTER BEING PRESCRIBED AN UNKNOWN ANTIBIOTIC AND LASIK SURGERY, THEY HAVE ALMOST FULLY RECOVERED AS THE SCARRING IS HEALING. FOLLOW UP WITH THE TREATING DOCTOR INDICATES THEY HAVE NO RECORD OF THE PATIENT USING THE COMPLAINT PRODUCT. THEY VISITED THE OFFICE WITH LEFT EYE PAIN, STINGING, FOREIGN BODY SENSATION AND LIGHT SENSITIVITY. THEIR EYESIGHT REMAINED 20/20 WITH CONTACT LENSES. THEY WERE DIAGNOSED WITH LEFT EYE FOCAL KERATITIS, SUPERFICIAL PUNCTATE KERATOPATHY AND LEFT FAINT CENTRAL CORNEAL SCAR. THEY WERE TREATED WITH ACULAR LS. THE DOCTOR INDICATES THEY DO NOT WISH TO PROVIDE ADDITIONAL MEDICAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184204 RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN BAUSCH & LOMB INCORPORATED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention