BEUDAMED
    FDA Adverse Event Summary report: N

    SUMMIT OMNIMED OR EXCIMED

    MDR report key: 219411 · Received April 15, 1999

    Report

    Report Number
    MW1016148
    Date Received
    April 15, 1999
    Report Date
    April 15, 1999
    Manufacturer
    SUMMIT TECHNOLOGY, INC.
    Product Code
    LZS
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    LASIK AND AK PERFORMED BY MD ON 1/3/97, 3/25/97, 10/9/97 AND 1/15/98 WITH EXCIMER LASERS OR OTHERS MFG BEFORE 10/20/95. THE MD ALSO INTERPOSED A DEVICE CALLED THE ASTIGMATIC SLIT IN THE EXCIMER LASER BEAM ON 10/9/97 AND 1/15/98 TO PERFORM LASER AK. THE DEVICE WAS NOT FDA APPROVED. THE MD USED ONE OR TWO LASERS IN THE SURGERIES. THE FIRST LASER WAS PREVIOUSLY OWNED BUT WAS NOT UPGRADED AFTER 10/20/95. THE SECOND LASER WAS REIMPORTED FROM A FOREIGN COUNTRY, BUT WAS NOT UPGRADED AFTER 10/20/95. THE SURGERIES WERE DONE BY MD IN PART OR WHOLE WITH AN ABLATION ZONE OF 5.0 MM. THE INJURY IS DISABILITY IN THE RIGHT AND LEFT EYES, INCLUDING SUBSTANTIALLY BLURRED VISION AND ASTIGMATISM. A CLASS ACTION LAWSUIT WAS FILED ON 3/9/99 IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT OMNIMED OR EXCIMED EXCIMER LASER LZS SUMMIT TECHNOLOGY, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR