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Lasik folks -- PLEASE report your problems to the FDA, if applicable

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  • Lasik folks -- PLEASE report your problems to the FDA, if applicable

    Dear all --

    I'm eight years post-Lasik, still coping with night vision disturbances and dry eyes, and while I've done what I can talking to family and friends, worked with Rebecca on the website LaserMyEye, been a member here since this website started, and placed a front-page story on my local newspaper about my situation, I had never, ever, made such a report to the FDA.

    I reproduce below YGB's message . . . because it is by now submerged in the thread about the FDA meeting on April 25th.

    It took me about a half-hour to answer the questions, but only because I am chatty. Basically: what happened to you? what equipment was used? do you have objective evidence of your problem (dates, data/readouts/numbers)? what relevant history can you provide? (pre-existing conditions, etc.). You can skip items that don't apply, such as serial numbers of equipment, etc. At the very end you get to review your answers and have the opportunity to edit it all.

    Thanks again to YGB, Lucy, Natalie06, and Rebecca for urging us to let our voices be heard!

    mary (known to the "old-timers" as "gloomsburg" on SurgicalEyes)

    ===============================================
    Here's what YGB posted:

    No need for guilt. However, all LASIK sufferers should report their bad outcomes to the FDA. I posted this somewhere else, but here it is again ...

    If we want the FDA to know "how serious and widespread the problem is", it is imperative that we report our bad outcomes to the FDA.

    If you've been wondering how you can help or what you can do, this is it. If every LASIK patient who had a bad outcome filed a MedWatch report, the FDA would be flooded with adverse events reports. The web link below will take you to the "MedWatch Online Voluntary Reporting Form (3500)".
    Then click on the BEGIN button to the right of the page. The Patient Identifier field can be left blank. On the next page, for #1 click on "Adverse Event", for #2 click "Disability or Permanent Damage" (assuming that is applicable to you), on #5 describe the problem, and #6 is not applicable to LASIK.

    https://www.accessdata.fda.gov/scrip...tch-online.htm

    Note that you can always leave fields blank and still move on from one screen to the next. However, you should be able to fill in most of the fields using the steps above. Please do this. It would be great to get more than 140 complaints in less than a month.

  • #2
    Done!

    If you are having trouble with the above link, try...


    https://www.accessdata.fda.gov/scrip...tch-online.htm
    Never play leapfrog with a unicorn.

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    • #3
      Thanks, Mary! Rebecca - should we make this a sticky??

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      • #4
        Stuck!

        I've also added it to a new checklist for dry eye patients that I'm working on.

        The "140 complaints in 8 years" FDA line has powerfully motivated me to want to make a difference in this area... and not just with LASIK!

        What about all of you who are here because of another kind of surgery or medical procedure or drug? How many times have we heard people say here "Why didn't my doctor warn me?" or "I had no idea this could happen as a side effect of XXXX" or "Why isn't dry eye on the warning label of XXXX"? This is a potentially effective way of making our voices heard.

        If you have ANY temptation to think "My one little complaint won't make any difference" let me tell you, you're wrong! The meeting last Friday opened my eyes to the potential. Whatever the shortcomings of that meeting, there were some powerful new changes such as alteration to a terribly misleading section on dry eye and other important improvements to warnings on the FDA lasik website as well as the product labelling. That means it can happen with drugs and other devices as well!

        Here are my suggestions about situations where it may be useful to report your dry eyes to the FDA:

        1. If your dry eyes started after LASIK, PRK, LASEK, Epi-LASIK or other elective vision surgery, or cataract surgery. (If this is you, find out what laser was used in your surgery. You don't need the exact model. You can usually get this information from your surgeon's website, or you can call them to find out.)

        2. If your dry eye, or eyelid dysfunction resulting in dry eye, was caused by BOTOX injections.

        3. If your dry eye started or got worse after being on prescription or over-the-counter eyedrops of any kind. (All of you who were on BAK/BAC-preserved products at length with no warning? Time to speak up.)

        4. If your dry eyes started or got significantly worse after taking a systemic drug such as:
        • Antihistamines
        • Diuretics
        • Acne medications
        • Hormone replacement therapy
        • Beta blockers
        • Pain medications
        • Decongestant
        Rebecca Petris
        The Dry Eye Zone

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        • #5
          Last night I was looking at all the paperwork the Lasik place gave me (I guess I am a bit sadistic) and on the paperwork for the Visx Laser it said "Contraindicate for those with severe dry eye that does not respond to treatment." That was it on dry eye. I had NO dry eye pre-surgery that I was aware of and even if I was "boarderline" which they have conveniently told me now, I sure the heck wasn't severe!

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          • #6
            I was not even given the laser patient handbook -- I only found it after the fact online -- not easy to find on the website of my lasik place -- A University no less!

            It had some sobering stats about dry eye -- which would have been nice to read beforehand. It said that 36% of patients have dry eyes at 6 months. My pre-op mostly focused on what kind of vision I could get. Well, true I got cyrstal clear vision -- but I'd give it back in a heartbeat.

            I was explaining my situation to some friends and just said -- I don't think it's a good surgery b/c everyone heals too differently or not at all........

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            • #7
              This form says they want the suspected product and the suspected medical device name?

              Huh??????

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              • #8
                The manufacturer/model of the laser i.e. VISX, Bausch & Lomb, etc. You can find out by calling the laser center where it was done.
                Rebecca Petris
                The Dry Eye Zone

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                • #9
                  Originally posted by Raginator View Post
                  This form says they want the suspected product and the suspected medical device name?

                  Huh??????
                  The FDA will contact the manufacturer of the laser you had your surgery with and ask them to make a report on your case. After I filed my complaint with the FDA Bausch & Lomb contacted me trying to get permission to get my medical info from my lasik doc. I did not give them permission but maybe should have, at least then the lasik clinic I had the surgery at might have taken my complaints seriously.

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