BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4 IR EXCIMER LASER

    MDR report key: 3182881 · Received June 21, 2013

    Report

    Report Number
    3006695864-2013-00226
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    March 9, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS PART OF A CLINICAL STUDY. THE CLINIC DID NOT REQUEST OR REQUIRE FIELD SERVICE OR CLINICAL SUPPORT.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH SEVERE DRY EYE AT THE 3 MONTH POST OP EXAM. THE PATIENT BEGAN EXPERIENCING DRY EYE THE DAY AFTER THE TREATMENT AND HAS INDICATED THAT THEY ARE HAVING A LOT OF DIFFICULTY DRIVING AT NIGHT. THE PATIENT IS BEING TREATED WITH PUNCTAL PLUGS, REFRESH AND SYSTANE THREE TIMES A DAY, RESTASIS TWICE A DAY AND MURO 128 AS NEEDED AND AT BEDTIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282732 STAR S4 IR EXCIMER LASER EXCIMER LASER LZS ABBOTT MEDICAL OPTICS STAR S4 IR

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention