BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1870808 · Received October 11, 2010

    Report

    Report Number
    1033553-2010-00111
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 31, 2010
    Report Date
    October 11, 2010
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K032340
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACUVUE ADVANCE BRAND CONTACT LENSES GALYFILCON A. ONE-DAY ACUVUE TRUEYE CONTACT LENSES NARAFILCON A; PMA# -. K073485. DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    A PT CONTACTED OUR (B)(4) AFFILIATE ON (B)(6) 2010 TO REPORT DEVELOPING A CORNEAL ULCER IN THE LEFT EYE (OS). AT THE TIME OF THE INJURY, THE PT WAS WEARING ACUVUE ADVANCE CONTACT LENSES AND 1-DAY TRUEYE CONTACT LENSES NARAFILCON A. NARAFILCON A LENSES ARE NOT MARKETED IN THE UNITED STATES. THE PT WAS NOT SURE WHICH LENS WAS WORN AT THE ONSET OF THE SYMPTOMS. THE PT REPORTED THAT HE/SHE WAS SEEN AT A CLINIC ON (B)(6) 2010 AND WAS DIAGNOSED WITH POSSIBLE GLAUCOMA OS AND WAS PRESCRIBED 3 TYPES OF EYE DROPS, THE SPECIFIC MEDICATIONS WERE NOT PROVIDED. THE PT WAS INSTRUCTED TO RETURN TO THE CLINIC IF THE PAIN DID NOT RESOLVE. THE PT REPORTEDLY SLEPT AFTER GOING HOME AND AWAKENED WITH A FOREIGN BODY SENSATION AND PAIN OS AND "ALMOST COULD NOT SEE A THING OS." THE PT WAS SEEN AT AN EYE CLINIC THAT DAY, WAS DIAGNOSED WITH A "POSSIBLE CORNEAL ULCER" AND WAS REFERRED TO THE (B)(6) HOSPITAL. THE PT WAS SEEN AT THE EYE HOSPITAL ON (B)(6) 2010, WAS DIAGNOSED WITH A CORNEAL ULCER AND WAS PRESCRIBED ONE OPHTHALMIC EYE DROP; THE SPECIFIC MEDICATION IS UNK. THE PT WAS ALSO INSTRUCTED TO CONTINUE USING TWO OF THE EYE MEDICATIONS PREVIOUSLY PRESCRIBED. THE PT WAS SEEN FOR THREE FOLLOW-UP VISITS, THE THIRD VISIT WAS ON (B)(6) 2010. THE PT'S VISION HAD RETURNED TO PRE-INJURY STATUS AND THE PT HAD NO OCULAR SYMPTOMS. THE HOSPITAL CLINIC WAS CONTACTED ON (B)(6) 2010 REGARDING THIS INJURY; THE HOSPITAL REQUIRED A WRITTEN RELEASE FROM THE PT IN ORDER TO PROVIDE ANY INFO. WE ARE AWAITING THE PT'S WRITTEN RELEASE TO OBTAIN THE INFO. THE LOT NUMBERS OF THE ACUVUE ADVANCE CONTACT LENSES AND THE 1-DAY ACUVUE TRUEYE LENSES WAS NOT PROVIDED. AS A CORNEAL ULCER MAY OR MAY NOT BE A SERIOUS INJURY AND DETAILS OF LOCATION, SIZE, VISUAL ACUITY OR CONFIRMATION BY A MEDICAL PROFESSIONAL WERE NOT AVAILABLE, THIS EVENT IS BEING REPORTED AS WORST CASE. IF ADDITIONAL INFO IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN EXECUTIVE MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other