BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 1013926 · Received March 13, 2008

    Report

    Report Number
    MW5005887
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    April 26, 2007
    Report Date
    March 13, 2008
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LASIK SURGERY FOR NEARSIGHTEDNESS - LASER "SKIPPED" WHEN MAKING INITIAL CUT. LASER SCRAPED MY EYE, PREVENTING COMPLETION OF THE SURGERY IN ONE EYE - OTHER EYE COMPLETED SUCCESSFULLY DURING SAME APPOINTMENT. - HEALING OF THE SCRAPE TOOK ABOUT 4 MONTHS. ALSO LED TO SIGNIFICANT PAIN, LOST TIME AT WORK, AND PERIODIC "EROSIONS" IN MY EYE. VISION IN THAT EYE IS NOW CORRECTED WITH CONTACT LENS. EROSIONS STILL PERIODIC, BUT TREATED WITH STEROID AND LUBRICANT DROPS AS NEEDED. EROSIONS A YEAR LATER STILL CAUSE A GOOD DEAL OF PAIN AND LOST TIME AT WORK. WHEN NOT WEARING THE CONTACT LENS, CONTRAST IN THAT EYE IS GREATLY IMPACTED TO THE POINT THAT I CANNOT COMPLETE TASKS UP-CLOSE WITHOUT THE CONTACT, WHICH WAS NOT THE CASE PRIOR TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASIK LASIK LZS

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other