BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX FOR ASTIGMATISM

    MDR report key: 1884043 · Received October 14, 2010

    Report

    Report Number
    9681121-2010-00039
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    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

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A FOLLOW-UP MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED IMMEDIATED, SEVERE PAIN WHEN SHE INSERTED CONTACT LENS. THE LENS WAS REMOVED, CLEANED, AND REINSERTED INTO HER EYE. THE PATIENT REMOVED THE LENS AND WAS EXAMINED BY THE EYE CARE PROFESSIONAL. THE EYE HAD COMPLETE STAINING. THE PATIENT WAS EXAMINED BY AN OPHTHALMOLOGIST AND DIAGNOSED WITH TOXIC KERATITIS WITH COMPLETE STAINING OF THE CORNEA. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT, SHE EXPERIENCED BURNING PAIN IN HER RIGHT EYE. THE PATIENT STATES THAT SHE WAS DIAGNOSED WITH KERATITIS AND GIVEN A PRESCRIPTION FOR ANTIBIOTICS BY THE OPHTHALMOLOGIST. THE PATIENT STATED THAT SHE DID NOT USE THE ANTIBIOTIC PRESCRIPTION PER HER EYE CARE PROFESSIONAL'S RECOMMENDATION. SHE HAS PENDING FOLLOW-UP APPOINTMENT SCHEDULED. SHE STATED THAT SHE IS CURRENTLY WEARING GLASSES WITH SOME COMPROMISE IN HER RIGHT EYE VISION WITH NO DISCOMFORT UNLESS THE EYE IS CLOSED. ADDITIONAL INFORMATION RECEIVED FROM THE EYE CARE PROFESSIONAL STATES THAT THE PATIENT STILL HAS A "SPOT" THAT HE IS MONITORING. THE PATIENT HAS A SCHEDULED FOLLOW-UP APPOINTMENT. THE KERATITIS WAS FOUND TO BE CHEMICAL, AND THEREFORE NOT INFECTIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR OPTIX FOR ASTIGMATISM LENSES, SOFT CONTACT LPM PT. CIBA VISION BATAM 8439145

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R