BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX TORIC

    MDR report key: 2003741 · Received February 24, 2011

    Report

    Report Number
    9681121-2011-00009
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 25, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS UNDERWAY BY MFG/ IF ANY ABNORMALITY IS FOUND, A F/U REPORT WILL BE PROVIDED. THE PT INSTRUCTIONS FOR USE (IFU) AND THE PACKAGE INSERT (PI) SPECIFICALLY STATES IN SEVERAL PLACES THROUGHOUT THE DOCUMENTS, INCLUDING THE PRECAUTIONS SECTION AND THE ADVERSE EFFECTS SECTIONS THAT: THE EYE CARE PROFESSIONAL SHOULD CAREFULLY INSTRUCT PTS OF THE FOLLOWING PRECAUTION: REMOVE A LENS IMMEDIATELY IF THE EYE SHOULD BECOME RED OR IRRITATED. PTS SHOULD BE INSTRUCTED THAT IF ANY SIGNS OR SYMPTOMS, E.G. MODERATE TO SEVERE PAIN NOT RELIEVED BY REMOVING THE LENS, FOREIGN BODY SENSATION, COMFORT IS LESS COMPARED TO WHEN THE LENS WAS FIRST PLACED ON EYE, OCCUR, THEY SHOULD IMMEDIATELY REMOVE LENS AND CONTACT THEIR EYE CARE PROFESSIONAL IF THE PROBLEM CONTINUES AFTER REMOVAL OF THE LENS. (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A PT THAT HE NOTICED LENS DISTORTION BEFORE WEARING BUT WORE THE LENS. HE FELT DISCOMFORT BUT CONTINUED WEARING. AFTER AROUND 10 DAYS USE, PT FELT PAIN AND WENT TO SEE THE DR ON (B)(6) 2011. LEFT EYE CORNEAL ULCER DIAGNOSED. ANTISEPTIC EYE DROPS WERE PRESCRIBED. F/U VISITS WERE MADE ON (B)(6). ADD'L INFO WAS OBTAINED FROM THE TREATING EYE CARE CLINIC. THE CLINIC ADVISED THAT THE DEVICE IN USE AT THE TIME OF THE EVENT WAS DISPOSED OF, BUT REMAINING LENSES IN THE SAME CARTON WERE AVAILABLE AND WOULD BE FORWARDED FOR EVAL. SCARRING IS POSSIBLE, BUT UNCONFIRMED AT THIS TIME AND THE EVENT WAS CONSIDERED "NOT SO SERIOUS" BY CLINIC STAFF. F/U INFO RECEIVED (B)(6) 2011 FROM THE PT INDICATED THAT THE DR'S INITIAL PRESCRIBE WAS "EYE DROP IN EVERY 2 HOURS" BUT IT CHANGED TO "EYE DROP 4 TIMES A DAY" (DURATION NOT PROVIDED). PT WAS INSTRUCTED TO RETURN TO CLINIC UPON COMPLETION OF USE OF EYE DROPS. SEVERAL REQUESTS HAVE BEEN MADE FOR PT PRIVACY RELEASE AUTHORIZATION, BUT HAS NOT BEEN RECEIVED AT THIS TIME. NO FURTHER DETAILS HAVE BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR OPTIX TORIC LENS SOFT EXTENDED WEAR LPM PT CIBA VISION BATAM 0503087

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention