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TODAY IS THE DEADLINE to submit your comments to the FDA about LASIK

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  • TODAY IS THE DEADLINE to submit your comments to the FDA about LASIK

    I apologize for not posting this here sooner. There have been references to the upcoming FDA meeting in other threads but I just noticed last night that it did not have as much prominence as it should either here or on D'Eyealogues.

    So for those of you not already aware, here's the story in a nutshell:

    The FDA's Opthalmic Devices Panel, which is the branch that deals with approvals of lasers used in LASIK and similar surgeries, is conducting a special meeting on April 25th which is a unique opportunity to make consumer concerns about LASIK heard. The deadline for requesting a speaking slot has passed, but you can still submit WRITTEN comments to the FDA which will go on the record for this meeting. Needless to say it is very important that we make our concerns known.

    IF YOU HAVE HAD AN ADVERSE EXPERIENCE OF LASIK DRY EYE, due to any or all of the following:
    • Severity of your dry eye symptoms
    • Unexpectedness of your dry eye symptoms
    • How long your dry eye symptoms have lasted since surgery
    • Lack of effective treatments
    • Depression and/or anxiety related to the symptoms, experience, etc.
    • Overall life impact of your experience with LASIK dry eye


    PLEASE, PLEASE take the time to send in your comments, however brief, to the FDA contact person. THE DEADLINE IS TODAY, Tuesday, April 15th.

    You can email your comments to the FDA contact person, Karen Warburton, by close of business TODAY, April 15th.

    The bullet points above are my suggestions for what to write about. Brief and to the point is all that's needed.
    Rebecca Petris
    The Dry Eye Foundation
    dryeyefoundation.org
    800-484-0244

  • #2
    LASIK patiens...READ this reply to my email to the FDA:

    Every comment counts. Don't let the fact that they have already received a "large number" influence you. The MORE they get the MORE impactful we can be:

    Dear Author of Email comments regarding LASIK:

    You may have indicated in your original emails, or in response to a request, that you would like your comments included in the record of the Ophthalmic Devices Panel meeting. We want you to know that due to the large number of comments that have been received, your written comments:

    will be provided to the individual Panel members on April 25,
    placed in a notebook for the public to view on April 25, and
    will be posted on FDA's website after the meeting.

    Please note that all personal identifying information, including your name, address and phone number, will be removed in order to protect your privacy. Likewise, personal information of other persons that you may have identified in your comments will also be removed.

    Thank you again for taking the time to provide your comments.

    Comment


    • #3
      Hmmmm....

      ...a large number of comments? Could it be that there are more casualties out there than they thought?!

      I sent my story and was glad to do it.
      Never play leapfrog with a unicorn.

      Comment


      • #4
        Diana!!!!

        I just pm'd you!!!

        Comment


        • #5
          I had another thought

          Think of how many potential victims might be saved if they read our stories on the FDA website. Hopefully there will be a prominent link from the LASIK risks info.

          Natalie
          Last edited by Natalie06; 15-Apr-2008, 16:42. Reason: clarification

          Comment


          • #6
            Big, big THANK YOU to everyone who took the time to do this. It was/is a rare opportunity to make our voices heard.

            I sent in a letter on behalf of myself, LaserMyEye and The Dry Eye Company. The three points I addressed (in addition to relating my personal experience) were:

            (1) depression
            (2) lack of remediation for the top two postop problems (dry eye and vision quality reduction); and
            (3) failure of the voluntary post-market reporting system.

            My request of the FDA is that they put "black box" warnings on excimer lasers.
            Rebecca Petris
            The Dry Eye Foundation
            dryeyefoundation.org
            800-484-0244

            Comment


            • #7
              what do you mean by black box? like in airplanes?

              thanks so much for all that you do. I wonder how much effect these hearings will really have in the end.

              And do you know if PRK is being evaluated the same way? Or is this just for lasik?

              Comment


              • #8
                Originally posted by lboogie View Post
                what do you mean by black box? like in airplanes?

                thanks so much for all that you do. I wonder how much effect these hearings will really have in the end.

                And do you know if PRK is being evaluated the same way? Or is this just for lasik?
                A black box warning is the strongest warning the FDA can require on a product label.

                This hearing is specific to LASIK and phakic IOLs.
                Rebecca Petris
                The Dry Eye Foundation
                dryeyefoundation.org
                800-484-0244

                Comment

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