BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR CARE

    MDR report key: 1160965 · Received September 13, 2008

    Report

    Report Number
    MW5008306
    Event Type
    Injury
    Date Received
    September 13, 2008
    Date of Event
    September 13, 2008
    Report Date
    September 13, 2008
    Manufacturer
    CIBA VISION CORP
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    THIS IS THE SECOND PATIENT -FIRST NOT REPORTED- THAT I HAVE SEEN IN OUR CLINIC THAT HAS SUSTAINED AN OCULAR INJURY FROM CIBA VISION - PRODUCT CALLED CLEAR CARE. THE PATIENT ABOVE HAS SUSTAINED A SIGNIFICANT CORNEAL BURN USING THIS PRODUCT AS INSTRUCTED. THERE IS THE POTENTIAL FOR CORNEAL SCARRING AND LOSS OF VISION. DATES OF USE: ONCE: 2008. DIAGNOSIS OR REASON FOR USE: CONTACTS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR CARE NONE LPN CIBA VISION CORP 78424

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R