BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENU WITH MOISTURELOC MULTI-PURPOSE SOLUTION

    MDR report key: 617887 · Received June 27, 2005

    Report

    Report Number
    1313525-2005-00007
    Event Type
    Injury
    Date Received
    June 27, 2005
    Date of Event
    April 2, 2005
    Report Date
    May 17, 2005
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    LYL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTS WHILE AT A ROUTINE EYE EXAM, THE DOCTOR RINSED THEIR LENSES WITH A BOTTLE OF SOLUTION THAT WAS IN THE OFFICE. LATER THAT DAY, THE PATIENT'S EYE AND EYELIDS BECAME SWOLLEN AND THEY TELEPHONED THE DOCTOR WHO INSTRUCTED THEM TO TAKE BENADRYL. THE PATIENT REPORTS THE NEXT DAY THEIR EYES LOOKED WORSE AND THEY HAD DIFFICULTY BREATHING AND WENT TO THE HOSPITAL EMERGENCY DEPARTMENT. THE PATIENT REPORTS THEY WERE DIAGNOSED AS HAVING AN ALLERGIC REACTION TO THE PRODUCT AND RECEIVED AN INJECTION AND PRESCRIBED STEROIDS, AN ANTIBIOTIC, AND A PAIN KILLER. FOLLOWING TREATMENT, THE PATIENT RECOVERED AND RESUMED LENS WEAR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization