BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 LASER

    MDR report key: 18411219 · Received December 27, 2023

    Report

    Report Number
    MW5149650
    Event Type
    Injury
    Date Received
    December 27, 2023
    Date of Event
    June 9, 2023
    Report Date
    December 24, 2023
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    LZS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD WAVEFRONT OPTIMIZED LASIK WITH THE EX500 LASER FOR MODERATE MYOPIA (-5.00 TO -6.00 IN BOTH EYES, AND UP TO -.50 ASTIGMATISM IN BOTH). OVER 6 MONTHS PAST THE OPERATION DATE, I HAVE DIAGNOSED UNDERCORRECTION, DIAGNOSED .25 DIOPTERS WORSE ASTIGMATISM THAN BEFORE SURGERY IN ONE EYE. I ALSO HAVE WHAT IS LIKELY IRREGULAR ASTIGMATISM FROM HOAS (DISCUSSED WITH EYE SURGEON AFTER TOPOGRAPHY), DAYTIME STARBURSTS, NIGHTTIME STARBURSTS, HALOS, FLOATERS AND RAINBOW GLARE. SOFT TORIC LENSES AND GLASSES FOR ASTIGMATISM DID NOT HELP WITH THE GLARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2263943 WAVELIGHT EX500 LASER EXCIMER LASER SYSTEM LZS ALCON LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Disability WELLBUTRIN 150MG.| ZYRTEC 10MG.