BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR EYES CLR SOOTHING DROPS

    MDR report key: 122016 · Received September 22, 1997

    Report

    Report Number
    1528738-1997-00061
    Event Type
    Injury
    Date Received
    September 22, 1997
    Date of Event
    August 23, 1997
    Report Date
    September 19, 1997
    Manufacturer
    ROSS PRODUCTS DIV. ABBOTT LABORATORIES
    Product Code
    LPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT OPENED A NEW BOTTLE OF SOLUTION, PLACED HIS LENSES IN HIS EYES, THEN INSTILLED SEVERAL DROPS OF SOLUTION INTO HIS EYES. THE PT REPORTED AN IMMEDIATE BURNING SENSATION WITH THE PAIN GETTING MORE SEVERE OVER THE NEXT HR. THE PT REPEATED THE APPLICATION OF SOLUTION TO HIS EYES. THE PAIN CONTINUED TO GET WORSE WITH EXCESSIVE TEARING. THE PT WENT TO THE ER AND PRESENTED WITH RED, TEARING AND PAINFUL EYES. THE PHYSICIAN SWABBED THE EYES FOR CULTURE AND PERFORMED AN EXAM USING FLOURESCEIN DYE. NO ABRASIONS OR SCRATCHES WERE OBSERVED. THE PHYSICIAN SUSPECTED A CHEMICAL BURN TO THE EYES, POSSIBLE RELATED TO AN EXTREME PH. THE PHYSICIAN PRESCRIBED DAILY IRRIGATION AND A TOPICAL ANTIBIOTIC OINTMENT. THREE DAYS LATER, THE PT WAS SEEN BY AN OPHTHALMOLOGIST WHO DIAGNOSED A MINOR EYE INFECTION AND PRESCRIBED TOPICAL ANTIBIOTIC EYE DROPS. FIVE DAYS FOLLOWING THE EVENT, THE PT REPORTED HE FELT MUCH BETTER. ONE PT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR EYES CLR SOOTHING DROPS 86LPN CLEANING AND WETTING AGENTS LPN ROSS PRODUCTS DIV. ABBOTT LABORATORIES 6532-01 17-988-AW

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention NONE REPORTED.