BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S4-IR-ETL EXCIMER LASER

    MDR report key: 3182892 · Received June 21, 2013

    Report

    Report Number
    3006695864-2013-00225
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 24, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CLINIC IS REPORTING THIS ADVERSE EVENT ONLY AND DOES NOT REQUEST OR REQUIRE FIELD SERVICE OR CLINICAL SUPPORT.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT WHO RECEIVED PRK (PHOTOREFRACTIVE KERATECTOMY) TREATMENTS PRESENTED WITH CORNEAL ECTASIA IN EACH EYE. THE DOCTOR NOTED THAT THERE WAS A GREAT INCREASE IN ASTIGMATISM AND THIN SPOTS ON THE TOPOGRAPHY. THE DIAGNOSIS WAS APPROXIMATELY 4 1/2 YEARS AFTER THE INITIAL TREATMENT. THE PATIENT IS CURRENTLY CORRECTABLE TO 20/20 IN EACH EYE. THE PATIENT WAS REFERRED TO A SPECIALIST FOR FURTHER EVALUATION AND TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284111 S4-IR-ETL EXCIMER LASER EXCIMER LASER LZS ABBOTT MEDICAL OPTICS S4-IR-ETL

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other