BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIS CLENAING AND SOAKING SOLUTION

    MDR report key: 65843 · Received January 31, 1997

    Report

    Report Number
    2011068-1996-00053
    Event Type
    Injury
    Date Received
    January 31, 1997
    Date of Event
    October 1, 1996
    Report Date
    October 2, 1996
    Manufacturer
    ALLERGAN, INC.
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CO RECEIVED A REPORT THAT A FEMALE PT EXPERIENCED CHEMICAL KERATITIS, OCULAR PAIN AND INFLAMMATION (OD) AFTER THE TECHNICIAN RINSED THE PT'S LENSES WITH CLEANING AND SOAKING SOLUTION. THE TECH THOUGHT THE SOLUTION WAS A MULTI-PURPOSE SOLUTION. THE OPTOMETRIST RINSED THE PT'S EYE WITH AN IRRIGATING SOLUTION, APPLIED PROPARACAINE 0.5% AND AN ANTIBIOTIC (NEOMYCIN POLYMIXIN B) TO PRECLUDE PERMANENT INJURY. PT WAS SEEN AGAIN BY THE DR WITHIN 24 HRS AND SYMPTOMS SHOWED IMPROVEMENT. PT WAS TREATED WITH OCUFLOX ON THE SECOND VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARIS CLENAING AND SOAKING SOLUTION NI LPN ALLERGAN, INC. NI 33B2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention