BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR OPTIX AQUA

    MDR report key: 2103766 · Received May 24, 2011

    Report

    Report Number
    9681121-2011-00019
    Event Type
    Injury
    Date Received
    May 24, 2011
    Report Date
    April 26, 2011
    Manufacturer
    PT. CIBA VISION BATAM
    Product Code
    LPM
    PMA / PMN Number
    P010019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS ON THE SAME EVENT INVOLVING TWO PRODUCTS ON THE SAME PATIENT. REFER TO (B)(4) FOR A DESCRIPTION OF THE SECOND REPORT. IT WAS INITIALLY REPORTED BY THE OPTICIAN THAT A NEW CONTACT LENS WEARER EXPERIENCED SLIGHT SIGNS OF IRRITATION AFTER INITIAL INSERTION OF CONTACT LENSES. AFTER TWO DAYS OF CONTACT LENS WEAR SHE EXPERIENCED A PRESUMED ALLERGIC REACTION WITH TEARING, REDNESS, SWELLING, ITCHING AND BURNING SENSATION IN HER EYES. THE PATIENT WAS PRESCRIBED TREATMENT WITH STEROIDS. AT THAT TIME THE ALLERGIC REACTION WAS NOT THOUGHT TO BE RELATED TO CONTACT LENS WEAR. TWO WEEKS LATER THE PATIENT RESUMED CONTACT LENS WEAR AND AFTER INSERTION OF A NEW PAIR OF LENSES SHE IMMEDIATELY FELT AN ITCHING AND BURNING SENSATION IN HER EYES. TWO DAYS LATER HER WHOLE FACE WAS SWOLLEN AND SHE WAS UNABLE TO OPEN HER EYES. THE PATIENT WAS TREATED WITH SYSTEMIC AND TOPICAL STEROIDS. THE CONTACT LENSES WERE FROM THE TRIAL SET AND HAVE BEEN DISPOSED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011 FROM OPTICIAN STATES THE PATIENT WAS SEEN ON (B)(6) 2011 AND SEEMED TO HAVE IMPROVED BUT HAD NOT COMPLETELY RESOLVED. MEDICAL RECORDS WERE REQUESTED FROM THE PATIENT. ADDITIONALLY IT WAS REPORTED THAT MORE ALLERGY TESTS ARE PLANNED TO BE PERFORMED AT A HOSPITAL. THE PATIENT WAS REQUESTED TO BRING IN LENS CARE SOLUTION, SOLOCARE AQUA, FOR ALLERGY TESTING. NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other