BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR CARE 3% HYDROGEN PEROXIDE CLEANING & DISINFECTION SOLUTION

    MDR report key: 4466171 · Received January 24, 2015

    Report

    Report Number
    MW5040448
    Event Type
    Malfunction
    Date Received
    January 24, 2015
    Date of Event
    January 17, 2015
    Report Date
    January 24, 2015
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    LPN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USING CLEAR CARE CONTACT LENS 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SYSTEM, THE PLATINUM DISC CONTAINED IN THE DISINFECTING CONTAINER THAT IS PART OF THE SYSTEM FAILED TO EXHIBIT THE USUAL BUBBLES WHEN THE DISINFECTING SOLUTION WAS ADDED TO THE CONTAINER ALONG WITH THE CONTACT LENSES REQUIRING DISINFECTION. WHEN THE SOLUTION WAS USED WITH AN OLDER PLATINUM DISC, THE ...

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM THE REPORTER ON 03/04/2015: I RECEIVED A REPLACEMENT CLEAR CARE 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTION SOLUTION DIRECTLY FROM ALCON FOR A DEFECTIVE PRODUCT WHICH I ALSO REPORTED TO YOU ON 01/24/2015. THE REPLACEMENT PRODUCT HAS A DEFECTIVE PLATINUM NEUTRALIZING DISC IN THE CONTACT LENS DISINFECTING CASE PROVIDED WITH THE PRODUCT, CAUSING THE HYDROGEN PEROXIDE SOLUTION TO "OVER-BUBBLE" AND FLOW OUTSIDE OF THE CASE. WHEN COMPLETELY NEUTRALIZED, AS EVIDENCED BY THE CESSATION OF BUBBLING ACTION, THE CASE CONTAINS LESS THAN HALF THE REQUIRED SOLUTION NEEDED TO KEEP THE CONTACT LENSES HYDRATED. THE LOT NUMBER IS 235205F, EXPIRATION 2016/10. IT IS OBVIOUS THAT ALCON LABORATORIES HAS A QUALITY CONTROL PROBLEM AND, IF NOT CORRECTED, COULD POTENTIALLY CAUSE HARM TO THOSE CONTACT LENS USERS WHO DO NOT OBSERVE EITHER IT'S INACTION, OR OVER-REACTION, AND POTENTIALLY EXPOSE THEIR CORNEA TO UN-NEUTRALIZED HYDROGEN PEROXIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57096 CLEAR CARE 3% HYDROGEN PEROXIDE CLEANING & DISINFECTION SOLUTION CLEAR CARE 3% HYDROGEN PEROXIDE CLEANING & DISINFECTION SOLUTION LPN ALCON LABORATORIES, INC. 2349299F
    57097 CLEAR CARE 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTION SOLUTION LENS CLEANSER --- ALCON 235205F

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR