BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISX EXCIMER LASER

    MDR report key: 2421223 · Received January 11, 2012

    Report

    Report Number
    3006695864-2011-00155
    Event Type
    Injury
    Date Received
    January 11, 2012
    Date of Event
    December 8, 2011
    Report Date
    December 16, 2011
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    LZS
    PMA / PMN Number
    K000327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN AMO FIELD SERVICE ENGINEER EXAMINED THE LASER AT THE CUSTOMER LOCATION AND NO ISSUES WERE FOUND THAT WERE RELATED TO THE REPORTED EVENT. THE SYSTEM WAS KEPT CLEANED BY THE CLINIC STAFF. THE FIELD SERVICE ENGINEER RECOMMENDED TO THE CLINIC TO HAVE THEIR AUTOCLAVE SERVICED. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH STAGE 4 DLK FOLLOWING A LIFT FLAP VISION ENHANCEMENT PROCEDURE IN THE LEFT EYE. THE PATIENT WAS PRESCRIBED DUROZOL EVERY TWO HOURS, RESTASIS TWICE A DAY AND ARTIFICIAL TEARS. THE PATIENT'S UCVA AT THE LAST POST OP EXAMINATION ON (B)(6) 2012 IS 20/400 AND THE BCVA IS 20/30 IN THE OPERATIVE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISX EXCIMER LASER LZS AMO MANUFACTURING USA, LLC STAR S4 IR

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other