BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AOSEPT PLUS/CLEAR CARE

    MDR report key: 1663343 · Received April 19, 2010

    Report

    Report Number
    8020392-2010-00001
    Event Type
    Injury
    Date Received
    April 19, 2010
    Date of Event
    January 12, 2010
    Report Date
    February 16, 2010
    Manufacturer
    CIBA VISION CANADA, INC., STERILE MANUFACTURING (CVSM)
    Product Code
    LPN
    PMA / PMN Number
    K050250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE IS CONSIDERED AS A SIGNIFICANT EPITHELIAL LOSS. A MANUFACTURING INVESTIGATION IS UNDERWAY. IF ANY ABNORMALITY IS FOUND, A F/U REPORT WILL BE PROVIDED. (B) (4).

    Description of Event or Problem · 1

    AN EYE CARE PRACTITIONER REPORTED THAT A PT EXPERIENCED MODERATE BURNING SENSATION, LEFT EYE, AFTER LENS REMOVAL ASSOCIATED WITH USE OF CLEAR CARE LENS CARE SOLUTION. F/U INFO RECEIVED ON (B) (6) 2010 - EXAMINATION REVEALED SIGNIFICANT CORNEAL STAINING (>50%) AND EDEMA AFTER TWO WEEKS. REFERRED TO OPHTHALMOLOGY FOR FURTHER EVAL. DIAGNOSIS OF LIMBAL STEM CELL DEFICIENCY RELATED TO CHRONIC CONTACT LENS WEAR. TREATMENT CONSISTED OF DOXYCYCLINE 50 MG 1XD, PRESERVATIVE-FREE DEXAMETHASONE DROPS 2XD AND PRESERVATIVE-FREE ARTIFICIAL TEARS. EVENT RESOLVED WITH NO EFFECT ON VISUAL ACUITY. NO LENS WEAR FOR SIX MONTHS. CONSIDERING LASIK EYE SURGERY IN FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AOSEPT PLUS/CLEAR CARE LENS CARE SOLUTION LPN CIBA VISION CANADA, INC., STERILE MANUFACTURING (CVSM) NA 95452

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention NONE REPORTED