BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OTIX TORIC

    MDR report key: 2881594 · Received December 18, 2012

    Report

    Report Number
    9681121-2012-00038
    Event Type
    Injury
    Date Received
    December 18, 2012
    Report Date
    November 20, 2012
    Manufacturer
    PT CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OPENED AND UNOPENED SAMPLES WERE RETURNED FOR EVALUATION AND FOUND TO MEET MANUFACTURING SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD AND STERILIZATION RECORD ARE IN PROGRESS. (B)(4).

    Description of Event or Problem · 1

    THIS IS THE FIRST REPORT ON THE SAME PATIENT INVOLVING TWO PRODUCT LOT NUMBERS. REFER TO MEDWATCH 9681121-2012-00039 FOR A DESCRIPTION OF THE SECOND EVENT. AS REPORTED BY THE EYE CARE PROVIDER (ECP), A PATIENT EXPERIENCED AN INFECTION AS A RESULT OF CONTACT LENS WEAR. IT WAS REPORTED THAT IT IS AN ABSCESS THAT CAUSED PAIN, REDNESS AND INFECTION IN THE PATIENT'S RIGHT EYE. IT WAS FURTHER REPORTED THAT THE PATIENT HAS COMPLETED TREATMENT. HOWEVER, THE SPECIFIC TREATMENT WAS NOT SPECIFIED. THE PATIENT WOULD NOT PROVIDE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR OTIX TORIC LENSES, SOFT CONTACTS, EXTENDED WEAR LPM PT CIBA VISION BATAM 31029708

    Patients

    Seq Age Sex Outcome Treatment
    1 Other