BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE MOIST BRAND CONTACT LENSES

    MDR report key: 2736977 · Received September 6, 2012

    Report

    Report Number
    1033553-2012-00046
    Event Type
    Injury
    Date Received
    September 6, 2012
    Date of Event
    June 26, 2012
    Report Date
    September 6, 2012
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE LIMITED INFO AVAILABLE, NO FURTHER INVESTIGATION CAN BE CONDUCTED AT THIS TIME. IF ADDITIONAL INFO IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN EXECUTIVE MANAGEMENT REVIEW MEETINGS. METHOD CODES: DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. DEVICE DISCARDED-UNABLE TO FOLLOW UP.

    Description of Event or Problem · 1

    INFO WAS RECEIVED FROM OUR (B)(4) AFFILIATE. ON 8/11/2012, A PT REPORTED BEING SEEN AND TREATED FOR AN ADVERSE EVENT BY AN EYE CARE PROFESSIONAL (ECP) IN (B)(6) 2012. THE PT WAS WEARING 1-DAY ACUVUE MOIST BRAND CONTACT LENSES IN BOTH EYES. THIS REPORT IS BEING SUBMITTED FOR THE RIGHT EYE (OD). PLEASE REFER TO REPORT 1033553-2012-00047 FOR INFO REGARDING THE LEFT EYE (OS). ON 08/13/2012, THE TREATING ECP PROVIDED ADDITIONAL INFO. THE PT PRESENTED (B)(6) 2012 WITH C/O REDNESS AND PAIN OU. THE PT WAS DIAGNOSED WITH CORNEAL EROSION AND CONJUNCTIVITIS OU. OS: EROSION 1MM IN SIZE. OD: THE EROSION WAS SMALLER THAN OS. THE PT WAS TREATED WITH VIGAMOX AND ODOMEL 0.05% EYE DROPS. NO CULTURES WERE TAKEN. THE PT RETURNED FOR F/U (B)(6) 2012 AND ON (B)(6) 2012; THE PT'S "SYMPTOM IMPROVED BUT DID NOT RESOLVE." THE PT HAS NOT RETURNED FOR F/U SINCE (B)(6) 2012. THIS EVENT IS BEING REPORTED WORST CASE BECAUSE THE "ECP PRESUMES THAT THE SYMPTOM WAS RATHER SERIOUS." NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE PRODUCT IN QUESTION HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1-DAY ACUVUE MOIST BRAND CONTACT LENSES SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention