BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCIMER LASER

    MDR report key: 1824683 · Received August 23, 2010

    Report

    Report Number
    MW5017296
    Event Type
    Injury
    Date Received
    August 23, 2010
    Date of Event
    July 4, 2010
    Report Date
    July 20, 2010
    Manufacturer
    SUMMIT TECHNOLOGY, INC.
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LASER-ASSISTED IN-SITU KERATOMILEUSIS -LASIK- SURGERY WAS PERFORMED ON BOTH EYES IN 1996, WHEN FIRST APPROVED BY THE FDA. SINCE THEN, I HAVE SUFFERED MULTIPLE SIDE EFFECTS SUCH AS DRY EYES, STAR BURSTS, DIMINISHED NIGHT VISION RESULTING IN INABILITY TO DRIVE AT NIGHT, LOSS OF LASIK CORRECTION, AMONG OTHERS. ABOUT 10 YEARS AGO, BOTH EYES SUFFERED TEARS AND HOLES IN THE RETINA, REQUIRING LASER SURGERY. SINCE 04/2009, I'VE UNDERGONE TWO CATARACT SURGERIES ON MY RIGHT EYE; AN INITIAL SURGERY AND REPEAT SURGERY TO REPLACE THE IOL. ON (B)(6) 2010, I SUFFERED A COMPLETE RETINAL DETACHMENT RESULTING IN BLINDNESS IN THE RIGHT EYE. AFTER EMERGENCY SURGERY IN THE HOSPITAL UNDER GENERAL ANESTHESIA, THE VISION IS SLOWLY RECOVERING. DATES OF USE: (B)(6) 1996. DIAGNOSIS OR REASON FOR USE: MYOPIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCIMER LASER EXCIMER LASER LZS SUMMIT TECHNOLOGY, INC.
    2 MICROKERATOME NONE HNO SUMMIT TECHNOLOGY, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability