BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE NARAFILCON A

    MDR report key: 1871039 · Received October 8, 2010

    Report

    Report Number
    1033553-2010-00110
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    August 23, 2010
    Report Date
    October 8, 2010
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K073485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED.

    Description of Event or Problem · 1

    OUR (B)(4) AFFILIATE RECEIVED A REPORT OF AN ADVERSE EVENT FROM A PT'S SIBLING. THE INFO STATES THAT ON (B)(6)2010, THE PT EXPERIENCED PAIN IN BOTH EYES. THE PT WAS SEEN AT AN EYE CLINIC AND TOLD THAT THE PAIN WAS CAUSED BY THE PT'S CONTACT LENSES. THE PT WAS PRESCRIBED GATIFLO 0.3%, MYDRIN-M 0.4% AND HYALEIN MINI 0.3% EYE DROPS. THE PT'S SIBLING SAID THE PT RETURNED TO THE CLINIC FOR FOLLOW-UP CARE BUT THE OD DID NOT IMPROVE AND THE PT REQUESTED TO BE REFERRED TO AN EYE HOSPITAL CLINIC. ON (B)(6)2010, THE PT WAS REFERRED TO AN EYE HOSPITAL CLINIC AND WAS PRESCRIBED TOBRACIN 0.3% EYE DROPS AND LOXONIN TABLETS. THE PT'S SIBLING SAID THE PT WAS TOLD THE OD CORNEA HAD "PEELED OFF". THE PT'S PARENT WAS CONTACTED AND REPORTED THE PT STILL HAS SIGNIFICANT PAIN IN THE OD. WE DID NOT RECEIVE INFO REGARDING THE LEFT EYE. THE PT IS RECEIVING FOLLOW-UP CARE "ALMOST EVERY DAY" AND IS WEARING AN EYE PATCH ON THE OD. WE ARE AWAITING WRITTEN CONSENT FROM THE PT TO OBTAIN ADDITIONAL INFO FROM THE EYE CLINIC. A LOT HISTORY REVIEW WAS REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME. IT WILL BE SENT IN A FOLLOW-UP REPORT. THERE ARE NO OTHER SIMILAR COMPLAINTS, ASSOCIATED WITH THIS LOT NUMBER, IN OUR WORLDWIDE COMPLAINT DATABASE. 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 1-DAY ACUVUE TRUEYE NARAFILCON A SOFT CONTACT LENS LPL VISTAKON NA 5209520102

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention