BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX TORIC

    MDR report key: 2031353 · Received March 23, 2011

    Report

    Report Number
    9681121-2011-00012
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 21, 2011
    Manufacturer
    PT. CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THERE WAS NO PRODUCT RETURNED OR LOT INFORMATION PROVIDED, NO DETAILED INVESTIGATION CAN BE PERFORMED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    AN EYE CARE PROFESSIONAL REPORTED THAT AN UNSPECIFIED PT EXPERIENCED A CORNEAL ULCER, LEFT EYE, ASSOCIATED WITH WEAR OF AIR OPTIX TORIC CONTACT LENSES. THE EVENT WAS DIAGNOSED AS INFECTIOUS EVENT. A CULTURE WAS PERFORMED, HOWEVER, THE RESULTS WERE NOT PROVIDED. THE ULCER WAS LOCATED PERIPHERAL CORNEA AT 7-8 O'CLOCK WITH INFILTRATES PRESENT. TREATMENT CONSISTED OF ORAL AND TOPICAL ANTIBIOTICS. AN ANTIBIOTIC DRIP INFUSION WAS ADDED FOR NEXT 4 DAYS, THEN CHANGED TO ANTIBACTERIAL EYE DROPS ONLY. EYEGLASSES WERE BEING MADE FOR THE PT. INFLAMMATION AND CONGESTION WERE LIGHT. NO VISION LOSS. REQUEST HAS BEEN MADE FOR ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR OPTIX TORIC LENSES, SOFT CONTACT, EXTENDED WEAR LPM PT. CIBA VISION BATAM

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other