BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE NARAFILCON A

    MDR report key: 2031359 · Received March 23, 2011

    Report

    Report Number
    1033553-2011-00022
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    September 6, 2010
    Report Date
    March 23, 2011
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    K073485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED. NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    INFO REC'D FROM OUR (B)(4) AFFILIATE. ON (B)(6) 2011 A PT REPORTED EXPERIENCING AND BEING TREATED FOR A MEDICAL ADVERSE EVENT WHILE WEARING 1-DAY TRUEYE NARAFILCON A CONTACT LENSES (NARAFILCON A PRODUCT IS NOT MARKETED IN THE U.S.). ON (B)(6) 2011 THE TREATING EYE CARE PROFESSIONAL (ECP) PROVIDED ADD'L INFO. THE ECP STATED THAT THE PT PRESENTED ON (B)(6) 2010 WITH PAIN AND LIGHT SENSITIVITY IN THE RIGHT EYE (OD) AFTER SLEEPING IN THE LENSES FOR A "SHORT TIME." THE PT WAS DIAGNOSED WITH A CORNEAL ULCER AND IRITIS OD. THE ULCER WAS 1MM IN SIZE AND LOCATED SUPERIORLY ON THE CENTRAL CORNEA. THE ECP ALSO NOTED 1+ CELLS IN THE ANTERIOR CHAMBER OF THE OD. THE ECP "PRESUMES THAT THE ULCER WAS NON-INFECTIOUS." NO CULTURE WAS OBTAINED. THE PT'S CORRECTED VA WAS 1.5 (20/13). THE PT WAS TREATED WITH VIGAMOX, BRONUCK AND MYDRIN-P EYE DROPS. ORAL LOXONIN WAS PRESCRIBED FOR PAIN. THE LOT NUMBER OF THE PRODUCT IN QUESTION IS UNK. THE PRODUCT IN QUESTION HAS BEEN DISCARDED AND IS NOT AVAILABLE FOR EVAL. NO ADD'L INFO IS EXPECTED TO BE REC'D. BASED ON THE LIMITED INFO AVAILABLE, NO FURTHER INVESTIGATION CAN BE CONDUCTED AT THIS TIME. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other| R