BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPERION LTK

    MDR report key: 297956 · Received September 12, 2000

    Report

    Report Number
    MW4002874
    Event Type
    Malfunction
    Date Received
    September 12, 2000
    Date of Event
    January 1, 2000
    Report Date
    September 11, 2000
    Manufacturer
    SUNRISE TECHNOLOGIES INTL, INC.
    Product Code
    LZS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS COME TO RPTR'S ATTENTION THAT MISLEADING CLAIMS REGARDING SUNRISE TECHNOLOGIES' HYPERION LTK LASER ARE BEING PROMULGATED BY THE CO AND NORDEN LASER VISION ASSOCIATES. IN NORDEN'S 9/6/00 NEWS RELEASE - WHICH HAS BEEN DISSEMINATED BY SUNRISE TECHNOLOGIES - DIR PRAISES THE PROCEDURE AS "SO SAFE AND VIRTUALLY PAIN FREE"; THE NEWS RELEASE ALSO ERRONEOUSLY DESCRIBES TREATMENT WITH THE HYPERION LTK AS A "THREE-SECOND 'NO TOUCH' PROCEDURE." YET, THE NEWS RELEASE NEGLECTS TO MENTION THAT SUNRISE TECHNOLOGIES' LASER IS FDA-APPROVED ONLY FOR THE TEMPORARY REDUCTION OF HYPEROPIA, AS THE TREATMENT'S CORRECTIVE EFFECT HAS A TENDENCY TO DIMINISH SIGNIFICANTLY OVER TIME. FURTHERMORE, DURING AN 8/22/00 INTERVIEW, SUNRISE TECHNOLOGIES' PRESIDENT AND CEO RESPONDED TO CNNFN REPORTER'S QUESTION OF WHETHER THE HYPERION LTK HAS ANY SIDE EFFECTS BY STATING, "WHAT OUR CLINICAL TRIALS SHOWED WAS THAT IN TERMS OF LASER RELATED ADVERSE EVENTS, WE HAVE ZERO, SO IT REALLY HAS A FANTASTIC SAFETY PROFILE." THEN EXPLAINS THAT WHAT PTS USUALLY EXPERIENCE WITH THE TREATMENT IS "AN IMMEDIATE ABILITY TO SEE NEAR AND THEN USUALLY THEIR DISTANCE VISION IS IMPROVED BUT THEN IMPROVES EVEN MORE AS TIME GOES." RPTR BELIEVES THAT THESE STATEMENTS, ISSUED WITHOUT ANY WARNING ABOUT - AND IN DIRECT CONTRADICTION TO - THE TREATMENT'S HIGH REGRESSION RATE, ARE PURPOSELY MISLEADING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPERION LTK LASER LZS SUNRISE TECHNOLOGIES INTL, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other