BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX TORIC

    MDR report key: 2620592 · Received June 12, 2012

    Report

    Report Number
    9681121-2012-00025
    Event Type
    Injury
    Date Received
    June 12, 2012
    Date of Event
    March 15, 2012
    Report Date
    May 14, 2012
    Manufacturer
    PT CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OPENED AND UNOPENED PRODUCT WAS RETURNED FOR EVALUATION AND FOUND TO MEET SPECIFICATIONS. THE DEVICE HISTORY AND STERILIZATION RECORDS FOR THE RETURNED LENSES HAVE BEEN REVIEWED AND FOUND TO BE IN COMPLIANCE. MANUFACTURING INVESTIGATION OF THE AFFECTED LOT REVEALED THERE WAS NO NONCONFORMITY OR DEVIATION DURING THE MANUFACTURING PROCESS WHICH RELATED TO THE NATURE OF THE COMPLAINT. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS ON TWO DIFFERENT LOTS INVOLVING THE SAME EVENT FOR THE SAME PATIENT. TWO REPORTS ARE REQUIRED DUE TO THE INABILITY TO DETERMINE WHICH OF THE REPORTED LOTS WAS SPECIFICALLY INVOLVED IN THE EVENT. REFER TO MEDWATCH 981121-2012-00026 FOR THE SECOND REPORT ON THE ALTERNATE LOT REPORTED. AN EYE CARE PROFESSIONAL REPORTED A CORNEAL ULCER WAS DIAGNOSED ON A PATIENT ASSOCIATED WITH CONTACT LENS WEAR. AN UNSPECIFIED TREATMENT WAS PRESCRIBED AND LENS WEAR RESUMED. THE ISSUE RESOLVED. NO FURTHER INFORMATION IS 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 8596078

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention