BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR EYES CLR SOOTHING DROPS

    MDR report key: 257806 · Received January 4, 2000

    Report

    Report Number
    1528738-2000-00001
    Event Type
    Injury
    Date Received
    January 4, 2000
    Date of Event
    December 3, 1999
    Report Date
    December 6, 1999
    Manufacturer
    ROSS PRODUCTS DIVISION, ABBOTT LABORATORIES
    Product Code
    LPN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT USED THE EYE DROPS FOR THE FIRST TIME. HIS EYES STARTED BURNING AND WATERING AND BECAME VERY RED AND SENSITIVE TO LIGHT. PT WAS SEEN BY A PHYSICIAN ON THE FOLLOWING DAY AND WAS GIVEN RX EYEDROPS. PT INDICATED DURING THE ORIGINAL CALL THAT HIS EYES WERE BETTER BUT STILL A LITTLE SENSITIVE TO LIGHT. PHYSICIAN'S IMPRESSION WAS THAT THE PT HAD AN ALLERGIC REACTION TO THE EYE DROPS. PHYSICIAN STATED THE PT RECOVERED FROM THIS CONDITION. ONE PT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR EYES CLR SOOTHING DROPS 86 LPN ACCESSORIES TO CONTACT LENSES LPN ROSS PRODUCTS DIVISION, ABBOTT LABORATORIES 6532-01 47-716-AW

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention CONTACT LENSES.