BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR EYES CLR SOOTHING DROPS

    MDR report key: 258692 · Received January 11, 2000

    Report

    Report Number
    1528738-2000-00004
    Event Type
    Injury
    Date Received
    January 11, 2000
    Date of Event
    December 14, 1999
    Report Date
    December 15, 1999
    Manufacturer
    ABBOTT LABORATORIES ROSS PRODUCTS DIVISION
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER (IDENTIFYING SELF AS AN FDA INVESTIGATOR) RECEIVED A REPORT FROM AN EMERGENCY ROOM DOCTOR INVOLVING A PATIENT WHO USED THE SUBJECT PRODUCT. THE PATIENT HAD USED THE PRODUCT BEFORE. ON THIS OCCASION, THE PATIENT INSTILLED ONE DROP IN THE RIGHT EYE, WHICH IMMEDIATELY STARTED BURNING SO BADLY THAT THE PATIENT WENT TO THE EMERGENCY ROOM FOR TREATMENT. THE PHYSICIAN REPORTED THE PATIENT HAD RED BLISTERS IN THE EYE. THE PHYSICIAN STATED THE SUBJECT PRODUCT SHOWED NO EVIDENCE OF TAMPERING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention