BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4 IR EXCIMER LASER

    MDR report key: 3173628 · Received June 17, 2013

    Report

    Report Number
    3006695864-2013-00215
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    January 10, 2013
    Report Date
    May 24, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AMO FIELD SERVICE ENGINEER EVALUATED THE SYSTEM AT THE CUSTOMER LOCATION AND NO ISSUES WERE FOUND THAT RELATED TO THE REPORTED ISSUE. FIELD SERVICE PERFORMED ROUTINE CALIBRATIONS TO OPTIMIZE SETTINGS AND ALIGNMENTS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2013. PLACEHOLDER.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED AT THE THREE MONTH POST OP EXAM WITH CENTRAL ISLANDS IN EACH EYE FOLLOWING LASER SCRAPE PRK (PHOTOREFRACTIVE KERATECTOMY) PROCEDURES. A PRK ENHANCEMENT PROCEDURE IS SCHEDULED FOR LATER IN THE MONTH. THE CLINIC REPORTED THAT THERE WAS NO LOSS OF VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274010 STAR S4 IR EXCIMER LASER EXCIMER LASER LZS ABBOTT MEDICAL OPTICS STAR S4 IR

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention