BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRONT WAVE LASIK AND LTK

    MDR report key: 1876065 · Received October 9, 2010

    Report

    Report Number
    MW5017731
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    June 15, 2003
    Report Date
    October 9, 2010
    Product Code
    LZS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I SHOULD HAVE NEVER BEEN TOLD, "YOUR VISION CAN BE IMPROVED TOO, SHARPENED A LITTLE". MY WIFE HAD THE APPOINTMENT, I JUST WENT ALONG. I TOLD THE DR I'M JUST HER DRIVER. AFTER HE MADE HER EYE BEST FOR NEAR VISION, BETTER FOR DISTANCE BY MISTAKE. HE THEN TRIED TO MAKE HER EYE BEST FOR DISTANCE NOW BE BEST FOR NEAR. THIS TOOK A FEW TRIES, WHEN I ASKED DO WE HAVE TO COME ALL THE WAY TO (B)(6) EACH POST-OP, CAN'T WE SEE A DOCTOR IN (B)(6) HE SAID AGAIN "YOUR VISION CAN BE IMPROVED, SHARPENED A LITTLE". MY NEW WIFE SAID, "IF YOU CAN IMPROVE HIS VISION I'LL PAY FOR IT FOR HIS BIRTHDAY". THE FIRST TIME THE FRONT WAVE MACHINE WOULD NOT FIRE, DR SAID SOMETHING IS WRONG WITH MY MACHINE, WE'LL HAVE TO RESCHEDULE WHEN I FIND OUT WHAT'S WRONG. THEN A MAN OR SALES REP HELPED HIM. MY 20/25 WAS NOW 20/70. AFTER GIVING IT TIME, I ASKED CAN THIS BE REVERSED? "SURE", THE DR SAID, THEN HE MADE MY SAME EYE 20/150; 2003, 2004, 2005, 2008, 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRONT WAVE LASIK AND LTK LASIK LZS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention