BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR CARE

    MDR report key: 4093047 · Received September 10, 2014

    Report

    Report Number
    MW5038177
    Event Type
    Injury
    Date Received
    September 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    CIBA VISION CORP
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CLEAR CARE LENS CLEANER LIQUID, MADE BY CIBA VISION CORP, A NOVARTIS COMPANY, WAS PLACED ON CONTACT LENS AND PLACED ON THE EYE RESULTING IN BURNING OF THE EYES. OUTCOME: TEMPORARY HARM/INJURY. SUBSEQUENT RESEARCH RESULTED IN DISCOVERY THAT SOLUTION SHOULD NOT ENTER EYE. LABELING AND PACKAGING SHOULD INDICATE A CLEANING SOLUTION, NOT SIMILAR TO PRODUCTS THAT MAY BE PLACED IN THE EYE WITHOUT HARM. PRODUCT SHOULD BE PLACED NEAR AND SOLD WITH CLEANING PRODUCTS, NOT PERSONAL CARE PRODUCTS. PACKAGING AND DISPENSING OF LIQUID SHOULD NOT BE SIMILAR TO ANY OTHER CONTACT LENS SOLUTIONS. CLEAR LABELING STATING LIQUID CONTENT SHOULD NOT MAKE CONTACT EYE SHOULD BE MOST PROMINENT IMAGE ON PACKAGE. PRODUCT SHOULD NOT BE PRODUCED AT ALL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559757 CLEAR CARE CONTACT LENS SOLUTION LPN CIBA VISION CORP

    Patients

    Seq Age Sex Outcome Treatment
    1