BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY TRUEYE CONTACT LENSES NARAFILCON A

    MDR report key: 2210456 · Received August 8, 2011

    Report

    Report Number
    1033553-2011-00054
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    October 7, 2010
    Report Date
    August 9, 2011
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K073485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT CONTACTED OUR (B)(4) AFFILIATE ON 07/16/2011 TO REPORT AN ADVERSE EVENT WHILE WEARING 1-DAY ACUVUE TRUEYE CONTACT LENSES (NARAFILCON A). NARAFILCON A PRODUCT IS NOT MARKETED IN THE US. THE PT REPORTED THAT ON (B)(6) 2010, HE/SHE PURCHASED 1-DAY ACUVUE TRUEYE CONTACT LENSES. THE PT REPORTED ON (B)(6) 2010 HIS/HER RIGHT EYE (OD) BECAME RED WHILE AT WORK AND IT WAS HARD FOR THE PT TO SEE CLEARLY. THE PT ALSO REPORTED THAT THE OD LENS WAS STUCK TO HIS/HER EYE AND THE PT FORCEFULLY REMOVED THE LENS. ON (B)(6) 2010, THE PT SAW AN EYE CARE PROFESSIONAL (ECP). THE PT REPORTED THAT AT THIS TIME THE ECP FOUND SOMETHING STUCK TO THE CORNEA AND REMOVED IT AND THERE WAS CORNEAL STAINING. ON 07/19/2011, AN ASSOCIATE FROM OUR (B)(4) AFFILIATE CONTACTED THE TREATING ECP'S OFFICE AND RECEIVED THE FOLLOWING INFO. THE PT WAS SEEN IN THE OFFICE ON (B)(6) 2010. THE PT WAS DIAGNOSED WITH CORNEAL EROSION AND IRITIS OD. THE PT'S VA WAS REDUCED AT THE FIRST VISIT, VA ASSESSMENT WAS NOT PROVIDED. THE PT WAS PRESCRIBED CRAVIT, HYALEIN AND RINDERON 0.1%. ON 07/21/2011, AN ASSOCIATE FROM OUR (B)(4) AFFILIATE CONTACTED THE ECP'S OFFICE AND RECEIVED THE FOLLOWING ADD'L INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1-DAY TRUEYE CONTACT LENSES NARAFILCON A SOFT CONTACT LENS LPL VISTAKON NA 502101 (PARTIAL)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other