BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX FOR ASTIGMATISM

    MDR report key: 4223542 · Received October 29, 2014

    Report

    Report Number
    9681121-2014-00058
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    August 18, 2014
    Report Date
    October 3, 2014
    Manufacturer
    PT CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED AND THE COMPLAINT SAMPLE WAS NOT MADE AVAILABLE FOR EVAL. NO COMPLAINT OF MFG TREND WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A REPORT OF VISION LOSS AND EPITHELIAL LOSS ASSOCIATED WITH CONTACT LENS WEAR WAS RECEIVED FROM AN EYE CARE PROFESSIONAL (ECP) ON (B)(6) 2014. THE CONSUMER EXPERIENCED SWOLLEN EYELIDS, REDNESS, ADN A FOREIGN BODY SENSATION. MEDICAL ATTENTION WAS SOUGHT AND THE CONSUMER WAS DIAGNOSED WITH CORNEAL EROSION AND DRY EYE. NO BIOPSY WAS PERFORMED. NO CORNEAL ULCERS WERE IDENTIFIED. THE CONSUMER WAS PRESCRIBED OFLOXACIN FOUR TIMES A DAY. PRIOR TO THE EVENT THE CONSUMER'S VISUAL ACUITY WAS 20/20 OU AND AT THE FOLLOW UP VISIT ON (B)(6) 2014 WAS 20/30 +1 IN THE RIGHT EYE AND 20/25 -1 IN THE LEFT EYE. ON (B)(6) 2014 IT WAS REPORTED THAT THE CONSUMER IS DOING BETTER AND WAS REFITTED INTO A DIFFERENT BRAND CONTACT LENS. THE EYE CARE PROVIDER'S OFFICE INDICATED ADD'L INFO WOULD NOT BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692790 AIR OPTIX FOR ASTIGMATISM LENSES, SOFT CONTACTS, EXTENDED WEAR LPM PT CIBA VISION BATAM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other