FDA LASIK hearing on 4/25

[dianat]

I got the exact same letter today. I was equally as perplexed before I opened it. I thought I failed some sort of screening...

[blackberry]

Email reply

I filled out the FDA form via email and got an email reply that it had been accepted. It was very easy to do. It felt good to vent about my LASIK disaster; my guess is that the more responses they get, the more they will pay attention to us. Thanks for the reminder, Rebecca.

[MyDryEyes]

I did it too!!

I submitted a form even though I had PRK! I was glad to see that the form was general and not specific to LASIK. It felt good to get my word in. I really hope that all of this will do some good. Maybe it will even help to get some better solutions to this horrible, horrible side effect!!

MDE

[brockwells]

I submitted too!

I don't participate much on this thread, but I read it alot. I had lasik 2 years ago and suffer from dry eye as a result of the surgery. I submitted my report as well to the FDA after seeing the news reports and getting wonderful information on how to report adverse affects from Dry Eye Talk. I also got my mail confirmation from the FDA. And as a side note, Rebecca mentioned about the problem with lasik and malpractice--in my experience, she's right. I spoke to two attorneys about improper informed consent regarding lasik and they said in their opinion, I took the risks and there were too many people with success stories. I was appalled. I even tried to talk to my surgery center's administrator to make changes to the consent form (at least to include a great deal of information about dry eye), and it still has not been changed, I want to protect other people from going through what I'm experiencing with this dry eye. Whenever I hear someone even mention Lasik, I'm telling them my experience! Needless to say, I'm extremely dissapointed in my healthcare system and how it really does protect the medical community and undermine patient consent. And remember, The FDA is even leaning toward providing medical device manufactors more protection from liability. Dennis Quaid testified this week to Congress about how we as the public need to have the right to sue medical device and pharmaceutical companies. So I've finally feel that I've been heard, thanks to your website and instructions on how to report to the FDA. Thank you so much!

[Natalie06]

Brockwell

Is your surgeon a member of the American Academy of Ophthalmology? Most of them are and if so, I would strongly encourage you to file a complaint with them. They have some specific guidelines for RS surgeons and IC and dry eye is one of them.

I can tell you from personal experience that my surgical practice changed their IC document and video and are now required by both the AAO and my state medical board to have personal conversations about dry eye with each and every patient and it's to be done by the surgeon...not the nurse or the Lasik coordinator.

You can make a difference and you already have by filing your experience with the FDA. Thank you

[brockwells]

doctor is AAO member

My surgeon and all his partners are AAO members. I will get with the AAO and report. I'll also let my surgeon's administration know as well that I am. I'll let you know what happens and thanks for the information.

[MyDryEyes]

Does anybody know how to file a complaing with the AAO?

MDE

[Natalie06]

AAO Ethics committee challenges

Send submissions to:
Ethics Committee
American Academy of Ophthalmology
P.O. Box 7424
San Francisco, CA 94120-7424


Inquiries or Challenges may be submitted by ophthalmologists (whether or not they are Fellows or Members of the Academy), other physicians, health care institutions, health care reimbursers, allied health professionals, patients and their families or organizations representing any of these.


If you go to www.aao.org you can read their very specific policies regarding theri code of ethics, informed consent, etc.

[m_cncl]

Unfortunately, some lasik doctors who perform the procedures are part of the academy of opthamology and in addition, a couple of them i know, who owe a few lasik clinics, are university/college professors,still teaching. However, even if the FDA changes a few lines, people will still get their lasik somewhere else, in a another country.
I attended the FDA meeting and it was discouraging because no one in govt cares. they all wore glasses, that says something. They'll perform the procedure but they do not want to be a Ginny pig, suffering the unforeseeable event.
The way to discourage lasik is hurting their pocket book. I have so far discourage 5 people in not performing lasik..m

[brd888]

Youtube

Just to say many of the testimonies at the FDA Lasik hearing have now been uploaded to youtube.

[YGB]

FDA LASIK complaints have dramatically increased in 2008!!

Thanks to many of you, there have been 271 FDA MedWatch reports filed just this year, and 224 of them just since April 1.

Therefore, 2008 alone has nearly doubled the number of complaints for the entire 10-year period prior to 2008.

For those of you who have yet to file your MedWatch report, please do. The instructions are located at the following link ...

http://www.lasermyeye.org/forums/showthread.php?t=2222

Your report can and will make a difference!

[Guest]

YGB

Is this reporting only available for those of you living in the US.

I am sure that we would have a similar body in the UK.

Great work

Ian

Edit: Just found out it is only available to US patients. Sorry. Should have checked before asking a stupid question. Ia

[Aaron77]

YGB

Is this reporting only available for those of you living in the US.

I am sure that we would have a similar body in the UK.

Great work

Ian

Edit: Just found out it is only available to US patients. Sorry. Should have checked before asking a stupid question. Ia

I reported my complications through the medwatch program and I'm in Canada. The FDA contacted Bausch and Lomb about my report and B&L has subsequently sent out a release of medical info form to me as part of their "investigation". Has anybody had a similar experience regarding their complaints? I figure its mainly B&L covering themselves legally and not sure if they are suppose to report back to the FDA.

[bernmee]

Not me...didn't think the FDA took much notice of complaints regarding Lasik.

Good to hear they did in your case...did you file the complaint through their website?

Bernadette

[Aaron77]

yes, I filed the complaint online through the FDA's medwatch program.

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