BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNRISE TECHNOLOGIES

    MDR report key: 311490 · Received January 4, 2001

    Report

    Report Number
    MW1020777
    Event Type
    Injury
    Date Received
    January 4, 2001
    Date of Event
    June 15, 1994
    Report Date
    January 4, 2001
    Manufacturer
    SUNRISE TECHNOLOGIES
    Product Code
    HQF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD "LTK" BY HOLMIUM LASER MFG BY SUNRISE TECH. AFTER 6 YEARS RPTR HAS DEVELOPED A SEVERE IRREGULAR ASTIGMATISM THAT MAY LEAD TO THE NEED FOR A CORNEA TRANSPLANT. THE MACHINE IS DANGEROUS AND MUST BE DEREGULATED AS LONG TERM STUDY IS NOT COMPLETE. RPTR HAD IT DONE IN ANOTHER COUNTRY THERE WAS A SECOND APPLICATION FOR A FINE TUNING BUT THE MACHINE MISFIRED AND OVERDID IT. READING WAS FINE FOR 5 YEARS BUT DETERIORATED RAPIDLY OVER THE LAST 3 TO 4 MONTHS. RPTR IS NOW LEGALLY BLIND IN THAT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376 SUNRISE TECHNOLOGIES HOLMIUM LASER HQF SUNRISE TECHNOLOGIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other| R