BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLEAR CARE

    MDR report key: 5187190 · Received October 26, 2015

    Report

    Report Number
    MW5057447
    Event Type
    Other
    Date Received
    October 26, 2015
    Date of Event
    January 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    CIBA LENS SOLUTION
    Product Code
    LPN
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLEAR CARE LENS CLEANER LIQUID, MADE BY (B)(6)., WAS PLACED ON CONTACT LENS AND PLACED ON THE EYE RESULTING IN BURNING OF THE EYE. MEDICATION ADMINISTERED TO OR USED BY THE PATIENT: NO. WHEN AND HOW WAS ERROR DISCOVERED: ERROR RESULTED IN DISCOVERY THAT SOLUTION SHOULD NOT ENTER EYE. PATIENT COUNSELING PROVIDED: UNKNOWN. REPORTER'S RECOMMENDATIONS: 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
    709606 CLEAR CARE CONTACT LENS SOLUTION LPN CIBA LENS SOLUTION

    Patients

    Seq Age Sex Outcome Treatment
    1