BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS

    MDR report key: 3093603 · Received May 1, 2013

    Report

    Report Number
    1033553-2013-00041
    Event Type
    Injury
    Date Received
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    VISTAKON
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING SINGLE USE OR REUSE. NO EVALUATION WILL BE PERFORMED. NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    ON (B)(6) 2013, OUR FIRM WAS MADE AWARE OF A TELEVISION NEWS REPORT OF A PATIENT WITH ACANTHAMOEBA KERATITIS OS. IN THE VIDEO, THE PATIENT IS SHOWN HANDLING A PACKAGE OF ACUVUE OASYS BRAND CONTACT LENSES THOUGH THE PRODUCT WAS NOT DIRECTLY IDENTIFIED AS BEING WORN AT THE TIME OF THE INJURY. A LOT NUMBER WAS VISIBLE BUT IT HAS NOT YET BEEN CONFIRMED IF THIS IS THE LOT ASSOCIATED WITH THE INJURY. WE HAVE CONTACTED THE REPORTER WHO HAS FORWARDED EMAIL TO THE PARENTS OF THE PATIENT AND WE HAVE BEEN CONTACTED BY A PARENT RECENTLY. ATTEMPTS ARE ONGOING TO SPEAK DIRECTLY WITH A PARENT. A DEVICE HISTORY REVIEW WAS PERFORMED: THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. NO QUALITY EVENTS ASSOCIATED WITH THIS LOT. THE LOT HISTORY REVIEW INDICATED LOT L001TGG WAS MANUFACTURED UNDER NORMAL CONDITIONS. IF ADDITIONAL INFORMATION IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188990 ACUVUE OASYS SOFT CONTACT LENS LPM VISTAKON NA L001TGG

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other| R