BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR S4-IR-ETL

    MDR report key: 3081378 · Received April 26, 2013

    Report

    Report Number
    3006695864-2013-00135
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 3, 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 CLINIC IS REPORTING THIS ADVERSE EVENT ONLY AND DID NOT REQUEST OR REQUIRE 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 WITH EPITHELIAL INGROWTH IN THE RIGHT EYE AND HAD A FLAP LIFT AND SCRAP ON (B)(6) 2013. THE PATIENT RETURNED ON (B)(6) 2013 AND TWO ISOLATED ISLANDS SUPERIOR TO THE PUPIL WERE DIAGNOSED IN THE RIGHT EYE. THE PATIENT'S FLAP WAS LIFTED AND THE BED SCRAPED. TISSUE GLUE WAS APPLIED TO THE EDGE TO PREVENT REGROWTH. AT THE ONE DAY FOLLOW-UP EXAM THE PATIENTS UNCORRECTED VISUAL ACUITY IN THE RIGHT EYE WAS 20/40 AND BANDAGED CONTACT LENS WAS IN PLACE. THE EVENT OF (B)(6) 2013 WAS REPORTED TO THE MANUFACTURER ON (B)(6) 2013 AND A MEDWATCH REPORT WAS SUBMITTED REF 3006095864-2013-00060.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180774 STAR S4-IR-ETL EXCIMER LASER LZS ABBOTT MEDICAL OPTICS S4-IR-ETL

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention