BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4 IR EXCIMER LASER

    MDR report key: 2802853 · Received October 24, 2012

    Report

    Report Number
    3006695864-2012-00168
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 28, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    LZS
    PMA / PMN Number
    P930016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CLINIC IS REPORTING THIS PATIENT EXPERIENCE ONLY AND DID NOT REQUEST FIELD SERVICE OR CLINICAL SUPPORT. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CLINIC REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED POST OPERATIVELY WITH CORNEAL ECTASIA AND IRREGULAR ASTIGMATISM IN THE LEFT EYE WHICH CAUSED A RAPID DECREASE IN VISION. THE PATIENT'S LASIK TREATMENT WAS PERFORMED ABOUT 5 YEARS EARLIER. THE SURGEON HAS SENT THE PATIENT INFORMATION TO A SPECIALIST TO DETERMINE IF THE PATIENT IS A CANDIDATE FOR CROSSLINKING. THE PATIENTS UNCORRECTED VISUAL ACUITY IN THE LEFT EYE IS 20/400 AND THE BEST CORRECTED VISUAL ACUITY IS 20/25.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other