BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAR CARE LENS CARE SOLUTION

    MDR report key: 1821525 · Received August 27, 2010

    Report

    Report Number
    8020392-2010-00010
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    CIBA VISION CANADA, INC., STERILE MANUFACTURING (CVSM)
    Product Code
    LPN
    PMA / PMN Number
    K030522
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS CONSIDERED AS A SIGNIFICANT CORNEAL ABRASION. AN EVALUATION OF THE RETURNED PRODUCT IS UNDERWAY BY MANUFACTURING. (B)(4).

    Description of Event or Problem · 1

    A USER REPORTED THAT SHE EXPERIENCED SEVERE BURNING AND REDNESS ASSOCIATED WITH USE OF CLEAR CARE LENS CARE SOLUTION. SUBSEQUENT MEDICAL INFORMATION CONFIRMED A SUBSTANTIAL CORNEAL ABRASION AND MILD SPK (SUPERFICIAL PUNCTATE KERATITIS) WITH "SEVERE STAINING" COVERING GREATER THAN 50% OF THE CORNEAL SURFACE. TREATMENT CONSISTED OF TOBRADEX 4X DAY FOR 3-5 DAYS. A FOLLOW UP VISIT WAS SCHEDULED. REQUEST HAS BEEN MADE FOR ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR CARE LENS CARE SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN CIBA VISION CANADA, INC., STERILE MANUFACTURING (CVSM) NA 97531

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NONE REPORTED