BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE TRUEYE NARAFILCON A

    MDR report key: 2092566 · Received May 3, 2011

    Report

    Report Number
    1033553-2011-00032
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    September 7, 2010
    Report Date
    May 3, 2011
    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. 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 PAIN AND REDNESS IN THE LEFT EYE (OS) WHILE WEARING 1-DAY TRUEYE NARAFILCON A CONTACT LENSES (NARAFILCON A PRODUCT IS NOT MARKETED IN THE U.S.) THE PT REPORTED PRESENTING TO AN EYE CARE PROFESSIONAL FOR EVAL BECAUSE THE REDNESS OS DID NOT RESOLVE AFTER THE LENS WAS REMOVED. ON (B)(6) 2011, THE PT'S EYE CARE PROFESSIONAL (ECP) CONFIRMED THAT THE PT INITIALLY PRESENTED (B)(6) 2010. THE PT WAS DIAGNOSED WITH "CORNEAL EROSION (CORNEAL EPITHELIUM DISORDER) AND IRITIS" OS LOCATED "SLIGHTLY LOWER FROM CTR, A LITTLE BIT LOWER NASAL, OFF PUPIL, OVAL" AND THAT THE DEPTH WAS "NOT SHALLOW RATHER DEEP." THE PT WAS PRESCRIBED CRAVIT AND FLUEMTHOLON 0.1% DROPS AND INSTRUCTED TO D/C CONTACT LENS WEAR. THE PT PRESENTED FOR F/U VISITS ON (B)(6) 2010 AND ON (B)(6) 2010 THE ECP CONFIRMED THAT BOTH THE CORNEAL EROSION AND THE IRITIS HAD RESOLVED. 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 E 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 MGMT REVIEW MGR.

    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 UNK Required Intervention