BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASIK

    MDR report key: 2220440 · Received August 17, 2011

    Report

    Report Number
    MW5021803
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    June 12, 2008
    Report Date
    August 17, 2011
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HAD LASIK IN (B)(6) 2008 WITH REFRACTIVE ERROR OF +725 IN RIGHT EYE AND +525 IN LEFT EYE. HAD GOOD INITIAL VISION, BUT HAD HALOS AND STARBURSTS AT NIGHT. YEAR LATER, RIGHT EYE REGRESSED HAD ENHANCEMENT. HELPED A LITTLE. IN 2011, RIGHT EYE AND LEFT EYE HAVE SLIPPED. I WAS TOLD I WOULD BE ABLE TO WEAR CONTACTS POST LASIK, BUT AM UNABLE TO BE FIT WITH THEM. EYE EXAMS ARE DIFFICULT DUE TO THE GLARES OFF OF THE SNELLEN CHART. WHAT WAS SUPPOSED TO MAKE MY LIFE MORE CONVENIENT HAS DONE THE OPPOSITE. HAD SURGERY IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASIK CUSTUMVUE INTRA LASE LZS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention