BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR CARE

    MDR report key: 2993874 · Received March 1, 2013

    Report

    Report Number
    8020392-2013-00001
    Event Type
    Injury
    Date Received
    March 1, 2013
    Report Date
    February 19, 2013
    Manufacturer
    CIBA VISION CANADA, INC.
    Product Code
    LPN
    PMA / PMN Number
    K031521
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THE LOT NUMBER IS UNKNOWN, THEREFORE FURTHER INVESTIGATION CANNOT BE PERFORMED. A TREND RELATED INVESTIGATION WAS PERFORMED. NO TREND COULD BE IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CONSUMER THAT IN (B)(6) 2012 FOLLOWING MONTHS OF USE WITH A LENS CARE SOLUTION, HE EXPERIENCED AN "ADVERSE EVENT." THE CONSUMER STATED THAT ALL BUT ONE LAYER OF THE CORNEA HAD BEEN BURNED OFF REFERRING TO IT AS "BURNED HIS CORNEA." HE SOUGHT MEDICAL CARE, BUT THE CONSUMER DID NOT PROVIDE SPECIFIC INFORMATION REGARDING HIS TREATMENT OR ANY MEDICATION. THE CONSUMER STATED THAT HE DID NOT WEAR HIS LENSES FOR 3-4 WEEKS AFTER THE INCIDENT, BUT GRADUALLY BUILT UP HIS WEARING TIME. HE HAS RESUMED LENS WEAR FULL TIME WITH NO ISSUES WITH RIGID GAS PERMEABLE LENSES. HE HAS A FOLLOW UP EXAMINATION SCHEDULED FOR (B)(6) 2013 REGARDING THIS SPECIFIC INCIDENT. THE CONSUMER DECLINED TO PROVIDE HIS CONTACT INFORMATION. NEITHER CONSUMER INFORMATION NOR EYE CARE PROFESSIONAL INFORMATION WAS PROVIDED. FOLLOW-UP IS NOT POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89849 CLEAR CARE LENS ACCESSORIES LPN CIBA VISION CANADA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other