BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 2770339 · Received October 1, 2012

    Report

    Report Number
    1033553-2012-00051
    Event Type
    Injury
    Date Received
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING SINGLE USE OR REUSE. DEVICE NOT RETURNED. NO EVALUATION WILL BE PERFORMED. NO CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    A PT'S SPOUSE CONTACTED OUR FIRM STATING THAT HIS WIFE HAD AN ADVERSE EVENT WHILE WEARING "YOUR PRODUCT." HE DID NOT INDICATE THE SPECIFIC PRODUCT NAME, WEAR SCHEDULED OR THE TREATING EYE CARE PROFESSIONAL'S INFO. HE STATED "THE LENS HAD A VERY RAGGED EDGE ON THE SIDE AND CUT HER EYE." HE STATED THAT THE PT HAD UNDERGONE SURGERY AND "NOW THERE IS A PERMANENT SCAR!" NO ADDITIONAL INFO IS AVAILABLE. OUR COMPANY HAS MADE NUMEROUS UNSUCCESSFUL ATTEMPTS TO OBTAIN ADDITIONAL INFO. THE PRODUCT IN QUESTION HAS BEEN REQUESTED BUT HAS NOT BEEN RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNK AT THIS TIME. IF ADDITIONAL INFO IS RECEIVED, WILL REPORT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED IN QUARTERLY MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other