Dr. Morris Waxler, former FDA chief of Ophthalmic Surgical Devices Branch, filed a citizen petition with the FDA calling for withdrawal of FDA approval for all LASIK devices and issuance of a Public Health Advisory in an effort to stop the epidemic of permanent eye injury.
“...the adverse event rate is 20%, twenty folder higher than the adverse event rate that was expected and approved under....”
“...Essentially the LASIK community lied and withheld data from the agency with regard to these events and distorted that information...”
DOWNLOAD Morris Waxler Lasik Petition
DOWNLOAD Fda's Interim Response to the Petition
http://www.thepetitionsite.com/1/support-petition-to-withdraw-lasik-approval/
11:11, Jan 11, Ms. Lynn Hamilton, VA
I am permanently disabled as a result of Lasik. My vision is 20/20 according to the ophthalmologist who mutilated my corneas. He tells me the procedure was successful; however, while viewing an object I see six (6) ghost images, starbursts and halos around EVERY light source and the severe dryness negates the 20/20 correction. My quality of my life has been RUINED, thanks to LASIK.
11:16, Jan 11, Name not displayed, AB
Almost 2 years ago my son had Lasik for hyperopia.The surgery left him with irreparable damage, double vision, that can not be corrected even by custom gas permeable lenses
11:36, Jan 11, Name not displayed, Turkey
Many complications appeared a few years later after having lasik on both eyes. Good result at first doesn't mean it will continue for life. I hope lasik ops can be stopped and a cure will be developed for lasik victims.
12:29, Jan 11, Joseph Schnell, PA
I am fully aware of the harm Lasik causes to all eyes it is performed on - there simply is a mountain of science that proves so. I had Lasik performed on both of my eyes and despite having been told I had a fairly good result, even by optometrists who are against Lasik, I know the quality of my vision and health of my eyes have suffered as a result of Lasik.
13:57, Jan 11, Mr. James Burke, CA
I've had my life ruined by lasik on 5-6-2009 by the latest lasik available.I was completely lied to about the safety of Lasik and destroyed.I'm now on Disability.Please stop destroying lives and warn the public of this horrible lasik procedure. PLEASE STOP LASIK AND HELP LASIK CASUALTIES.I need your help I've been injured so badly.
14:57, Jan 11, Name not displayed, FL
Like the previous posters Lynn Hamilton and James Burke, I am disabled from my chosen profession by the "temporary side effects"of this surgery which have lasted for years. As a direct result of this surgery, I no longer can see to drive at night and my night vision is obscured by huge starbursts and haloes. I also have permanent double vision in one eye due to a decentered ablation. This surgery also induced very painful dry eyes as well as a loss of multiple lines of best correctable vision.due to induced irregular astigmatism. Despite all these permanent unfixable complications, I am still considered a success by industry standards.
17:16, Jan 11, Name not displayed, AR
I am a physician who had LASEK done about 4 years ago. It has ruined my life. I cannot do what I studied my whole life for because of it. I am limited to certain services that I can provide because of my eyesight behind LASEK. People don't realize how long the rest of your life is if you have a bad outcome from this surgery. Above and beyond that, it is the most unethical procedure in the world.
17:51, Jan 11, Name not displayed, GA
I had LASIK in September, 2010. Prior to the surgery, I was a happy, healthy (in every way) young professional. I will never be that person again. Due to unbearable side effects - I have suffered from all the typical side effects (halos, starbursts, night vision problems) - plus severe depression, and even thoughts of suicide - something I never even thought myself capable of thinking of. I hope to God that this tragedy can be prevented for others.
18:30, Jan 11, Mr. Scott Schulz, GA
My girlfriend of 3 years has had her life turned upside down by this awful surgery. She scouted one of the top locations in the region and paid top dollar only to be left with seemingly permanent after effects. Down with LASIK and my support to your petition
09:55, Jan 11, Paula Cofer, FL
I suffered permanent, life-altering complications from LASIK. I know of thousands of people who also had a bad outcome from LASIK. Medical studies demonstrate that LASIK "side effects" are common, and that adverse effects are universal. LASIK surgeons do not fully inform potential patients, and are engaged in a cover-up. Clinical trials that the FDA relied upon were tainted by dishonest investigators.
19:43, Jan 11, Dr. Roger Davis, MO
I've communicated with over 300 people who've expressed a desire to end their life because of LASIK. Much of this is related to dry eye and night vision complaints. Victims all say the same thing: That their surgeon lied to them about the severity of complications, and continued to lie when they experienced a bad outcome. Time for this to stop.
20:01, Jan 11, Mrs. Brook Vanderford, CA
I had Lasik 2 1/2 years ago, and I am now visually disabled and cannot work or live my life free from pain. My eyes are so light sensitive that I can barely go outside, let alone use a computer or watch tv or be under non-natural lighting. No one seems to be able to help me in my condition either. I just keep getting told that this condition shouldn't have lasted this long (TLSS), as if that somehow addresses the issue. We need more research so this and other side effects don't keep happening.
05:39, Jan 12, Mr. Dean Andrew Kantis, FL
Because the world has been duped, the LASIK industry used falsified studies using only the good outcomes, and throwing away the bad outcomes, in order to get FDA approval...they cited lies that "there were no known long-term damages from LASIK" when they knew every flap never heals, kills vital corneal nerves needed to generate tears, further thins out corneas which progressivly ages the eye causing/inducing irregular higher order aberrations then needing corneal transplants, all while causing it's victims escalated depression and some suicidal tendencies because there is no cure.
05:59, Jan 12, Mr. Jason Jirovsky, IA
LASIK surgery was supposed to improve my quality of life. Instead, it has deteriorated the quality of life for not only me, but my family as well. I would give almost anything to go back. That in itself should say enough. Please discontinue this dangerous procedure until the long term side effects and additional corrective technologies can be developed. Thank you.
06:13, Jan 12, Ms. Catherine Stone, SC
I, like so many others, is a victim of LASIK surgery. I am now legally blind in both eyes and need a cornea transplant. PLEASE stop the butchering of healthy eyes
06:45, Jan 12, Mr. Richard McQueen, South Africa
How can patients sign an Informed Consent document if the side effects are not honestly shared?
06:55, Jan 12, Name not displayed, OH
I got LASIK in 2006 (at age 23) and it has ruined my life. I suffer from disabling pain that will most likely last forever. With no end in sight, I am becoming more and more suicidal with each day that passes. I don't truly want to die, but I do not want to "live" like this anymore. I can't.
07:07, Jan 12, Mr. Thurlough Smyth, NY
My friend, Colin Dorrian, took his own life after years of suffering negative outcomes of a LASIK procedure.
07:13, Jan 12, Gail Brion, KY
I have been left with compromised vision after LASIK. I have multiple images, halos, glare, loss of contrast sensitivity, and can no longer use a microscope. The side-effects of this surgery were downplayed and my negative results were not reported as part of the study that was ongoing at the time of my surgery. My university faculty surgeon calls me "functional" and considers my outcome acceptable. My worst decision was to have trusted him and the FDA with my vision. The FDA needs to admit and rectify its mistakes.
09:49, Jan 12, Ms. Mary Kurtz, PA
This issue is important to me because my nephew took his life when he was unable to live with the outcome to his eyes of lasik surgery.
11:05, Jan 12, Brittney Jaynes, GA
One of my closest friends had this surgery and she was so excited....until it completely changed her life and now she suffers everyday. She talked me out of doing LASIK and now I want everyone else to know that it is unnecessary and dangerous! Say yes to glasses and contacts and no to lasik!!!
17:23, Jan 15, Matt Kotsovolos, NC
I made the worst mistake of my life by having LASIK. LASIK damages a person's most vital sensory organ. Ruin a person's eyes and you ruin that person's life. It's that simple. The FDA should withdraw approval of LASIK and stop ruining many people's lives all for the sake of not wearing glasses or contact lenses. LASIK is not safe and effective. It's risky and deceptive. Why doesn't the FDA do it's job?
17:27, Jan 16, Mr. Gerard Dorrian, PA
Some of the adverse outcomes from LASIK surgery are outlined in this petition. What has not been examined here or elsewhere is how these outcomes impact patient’s lives. What impact do high order aberrations have on an individual’s ability to process visual information? What impact do visual distortions have on the psychological health of an individual? Following the FDA hearing in April of 2008 the public was assured that practitioners heard LASIK patients who have been damaged by this procedure. But what has changed? No efforts have been made to understand or address the problems that LASIK patients encounter.
05:13, Jan 17, Dr. Lauranell Burch, NC
LASIK clinical trials data that were the basis of FDA approval of the procedure are both incomplete and massaged to create the appearance that LASIK is safer than it is. As a scientist I felt I did my due diligence by reading the clinical trials data summary prior to my own surgery, only to find out that I and every other American who has undergone LASIK, was deceived. As a result, my eyes and the eyes of millions of Americans are permanently damaged by LASIK.
11:37, Jan 17, Esther Gabbrielli, NC
It is ridiculous that Lasik is sold as a no risk operation or low risk...piece of cake when many people experience debilitating eye problems afterward. There HAS to be a warning issued regarding the true safety of Lasik. Public health is at risk.
16:02, Jan 17, Name not displayed, KY
My life has been ruined because of lasik. Glasses or contacts can't fix my eyes because of lasik. My eyes are messed up forever. This lasik procedure needs to be stopped now, before more people have their eyes ruined. Lasik surgens are more interested money than telling the truth about how badly lasik can damage your eyes. I have sparklebursts, bad vision in low light and dark, starbursting, double and triple vision, severe glare, halos, light sensitivity, dry eyes, contrast loss, floaters that are worse since lasik. I have been on depression and anxiety medication since right after having lasik over four years ago. Please stop lasik from causing more people lives to be ruined!
06:11, Jan 18, Name not displayed, NC
I have a friend who had to go on disability because of lasik surgery. He and his family have suffered physically, emotionally and economically. The future for them is uncertain at best.
09:17, Jan 19, Mrs. Millie Hershner, NC
My 26 year old son had a retinal detachment in one eye within a month of having lasic surgery. He had retinal reattachment surgery and he now has a permanently scarred retina. There is significant scientific evidence that the suction applied to the eye during lasic surgery can cause a tearing of the retina by pulling on the vitreous humor in the eye.
10:32, Jan 19, Name not displayed, CA
My husband had LASIK in 2006, the suction broke as the laser was making a pass over the cornea, thus destroying it. He has endured years of surgeries as a result, including 2 corneal transplants, not to mention the loss of vision and pain. Our life revolves around this disability now. We have to plan trips carefully and be aware of where we might get help if needed while away from home. Our lives have been totally turned upside down by LASIK.
11:36, Jan 20, Brad Sandona, CA
I had it done two years ago, Severe eye damage, constant pain and PVD's with many eye floaters and guess what, I still need glasses! It is so dangerous, please put an end to it! I will never be the same, it has ruined my life and my wife's life.
12:56, Jan 20, Name not displayed, TX
My colleague who had LASIK surgery 5 years ago is now legally blind. It's ethically wrong for eye surgeons to ruin the lives of perfrctly healthy people just so they can make a few thousand dollars.
19:42, Jan 20, Mr. Nathan Jarnagin, NC
My life has been negatively changed forever. I suffer from chronic dye eye which is physically, emotionally, and financially debilitating. The public needs to be aware of the risks and the hazards associated with this elective surgery.
20:02, Jan 20, Name not displayed, CO
As far as the doctors who sell this surgery are concerned, the potential revenue of this surgery has always eclipsed the community of people who might suffer from it. Do some good science for once on this surgery... make 'em start over
07:49, Jan 24, Mr. Vipin Gupta, United Kingdom
I had thought of lasik 5 years ago and for my son as well later if it went well but after he turned 20. I knew eyes are probably the most important part of our lives and our jobs depend on them. I did a lot of research on the internet at that time and saw many negative comments and I postponed the idea until newer, better machines come up. But reading through all this now I thank God that I took time to make this decision and not go for LASIK. All these doctors are still advertising that it is safe and sound. Where is the greed leading to us? Not being able to drive at night? Not being able to go out in light? Constant dry eyes and pains? Multiple images? What else can they ruin to your life?
11:16, Jan 11, Name not displayed, AB
Almost 2 years ago my son had Lasik for hyperopia.The surgery left him with irreparable damage, double vision, that can not be corrected even by custom gas permeable lenses
11:36, Jan 11, Name not displayed, Turkey
Many complications appeared a few years later after having lasik on both eyes. Good result at first doesn't mean it will continue for life. I hope lasik ops can be stopped and a cure will be developed for lasik victims.
12:29, Jan 11, Joseph Schnell, PA
I am fully aware of the harm Lasik causes to all eyes it is performed on - there simply is a mountain of science that proves so. I had Lasik performed on both of my eyes and despite having been told I had a fairly good result, even by optometrists who are against Lasik, I know the quality of my vision and health of my eyes have suffered as a result of Lasik.
13:57, Jan 11, Mr. James Burke, CA
I've had my life ruined by lasik on 5-6-2009 by the latest lasik available.I was completely lied to about the safety of Lasik and destroyed.I'm now on Disability.Please stop destroying lives and warn the public of this horrible lasik procedure. PLEASE STOP LASIK AND HELP LASIK CASUALTIES.I need your help I've been injured so badly.
14:57, Jan 11, Name not displayed, FL
Like the previous posters Lynn Hamilton and James Burke, I am disabled from my chosen profession by the "temporary side effects"of this surgery which have lasted for years. As a direct result of this surgery, I no longer can see to drive at night and my night vision is obscured by huge starbursts and haloes. I also have permanent double vision in one eye due to a decentered ablation. This surgery also induced very painful dry eyes as well as a loss of multiple lines of best correctable vision.due to induced irregular astigmatism. Despite all these permanent unfixable complications, I am still considered a success by industry standards.
17:16, Jan 11, Name not displayed, AR
I am a physician who had LASEK done about 4 years ago. It has ruined my life. I cannot do what I studied my whole life for because of it. I am limited to certain services that I can provide because of my eyesight behind LASEK. People don't realize how long the rest of your life is if you have a bad outcome from this surgery. Above and beyond that, it is the most unethical procedure in the world.
17:51, Jan 11, Name not displayed, GA
I had LASIK in September, 2010. Prior to the surgery, I was a happy, healthy (in every way) young professional. I will never be that person again. Due to unbearable side effects - I have suffered from all the typical side effects (halos, starbursts, night vision problems) - plus severe depression, and even thoughts of suicide - something I never even thought myself capable of thinking of. I hope to God that this tragedy can be prevented for others.
18:30, Jan 11, Mr. Scott Schulz, GA
My girlfriend of 3 years has had her life turned upside down by this awful surgery. She scouted one of the top locations in the region and paid top dollar only to be left with seemingly permanent after effects. Down with LASIK and my support to your petition
09:55, Jan 11, Paula Cofer, FL
I suffered permanent, life-altering complications from LASIK. I know of thousands of people who also had a bad outcome from LASIK. Medical studies demonstrate that LASIK "side effects" are common, and that adverse effects are universal. LASIK surgeons do not fully inform potential patients, and are engaged in a cover-up. Clinical trials that the FDA relied upon were tainted by dishonest investigators.
19:43, Jan 11, Dr. Roger Davis, MO
I've communicated with over 300 people who've expressed a desire to end their life because of LASIK. Much of this is related to dry eye and night vision complaints. Victims all say the same thing: That their surgeon lied to them about the severity of complications, and continued to lie when they experienced a bad outcome. Time for this to stop.
20:01, Jan 11, Mrs. Brook Vanderford, CA
I had Lasik 2 1/2 years ago, and I am now visually disabled and cannot work or live my life free from pain. My eyes are so light sensitive that I can barely go outside, let alone use a computer or watch tv or be under non-natural lighting. No one seems to be able to help me in my condition either. I just keep getting told that this condition shouldn't have lasted this long (TLSS), as if that somehow addresses the issue. We need more research so this and other side effects don't keep happening.
05:39, Jan 12, Mr. Dean Andrew Kantis, FL
Because the world has been duped, the LASIK industry used falsified studies using only the good outcomes, and throwing away the bad outcomes, in order to get FDA approval...they cited lies that "there were no known long-term damages from LASIK" when they knew every flap never heals, kills vital corneal nerves needed to generate tears, further thins out corneas which progressivly ages the eye causing/inducing irregular higher order aberrations then needing corneal transplants, all while causing it's victims escalated depression and some suicidal tendencies because there is no cure.
05:59, Jan 12, Mr. Jason Jirovsky, IA
LASIK surgery was supposed to improve my quality of life. Instead, it has deteriorated the quality of life for not only me, but my family as well. I would give almost anything to go back. That in itself should say enough. Please discontinue this dangerous procedure until the long term side effects and additional corrective technologies can be developed. Thank you.
06:13, Jan 12, Ms. Catherine Stone, SC
I, like so many others, is a victim of LASIK surgery. I am now legally blind in both eyes and need a cornea transplant. PLEASE stop the butchering of healthy eyes
06:45, Jan 12, Mr. Richard McQueen, South Africa
How can patients sign an Informed Consent document if the side effects are not honestly shared?
06:55, Jan 12, Name not displayed, OH
I got LASIK in 2006 (at age 23) and it has ruined my life. I suffer from disabling pain that will most likely last forever. With no end in sight, I am becoming more and more suicidal with each day that passes. I don't truly want to die, but I do not want to "live" like this anymore. I can't.
07:07, Jan 12, Mr. Thurlough Smyth, NY
My friend, Colin Dorrian, took his own life after years of suffering negative outcomes of a LASIK procedure.
07:13, Jan 12, Gail Brion, KY
I have been left with compromised vision after LASIK. I have multiple images, halos, glare, loss of contrast sensitivity, and can no longer use a microscope. The side-effects of this surgery were downplayed and my negative results were not reported as part of the study that was ongoing at the time of my surgery. My university faculty surgeon calls me "functional" and considers my outcome acceptable. My worst decision was to have trusted him and the FDA with my vision. The FDA needs to admit and rectify its mistakes.
09:49, Jan 12, Ms. Mary Kurtz, PA
This issue is important to me because my nephew took his life when he was unable to live with the outcome to his eyes of lasik surgery.
11:05, Jan 12, Brittney Jaynes, GA
One of my closest friends had this surgery and she was so excited....until it completely changed her life and now she suffers everyday. She talked me out of doing LASIK and now I want everyone else to know that it is unnecessary and dangerous! Say yes to glasses and contacts and no to lasik!!!
17:23, Jan 15, Matt Kotsovolos, NC
I made the worst mistake of my life by having LASIK. LASIK damages a person's most vital sensory organ. Ruin a person's eyes and you ruin that person's life. It's that simple. The FDA should withdraw approval of LASIK and stop ruining many people's lives all for the sake of not wearing glasses or contact lenses. LASIK is not safe and effective. It's risky and deceptive. Why doesn't the FDA do it's job?
17:27, Jan 16, Mr. Gerard Dorrian, PA
Some of the adverse outcomes from LASIK surgery are outlined in this petition. What has not been examined here or elsewhere is how these outcomes impact patient’s lives. What impact do high order aberrations have on an individual’s ability to process visual information? What impact do visual distortions have on the psychological health of an individual? Following the FDA hearing in April of 2008 the public was assured that practitioners heard LASIK patients who have been damaged by this procedure. But what has changed? No efforts have been made to understand or address the problems that LASIK patients encounter.
05:13, Jan 17, Dr. Lauranell Burch, NC
LASIK clinical trials data that were the basis of FDA approval of the procedure are both incomplete and massaged to create the appearance that LASIK is safer than it is. As a scientist I felt I did my due diligence by reading the clinical trials data summary prior to my own surgery, only to find out that I and every other American who has undergone LASIK, was deceived. As a result, my eyes and the eyes of millions of Americans are permanently damaged by LASIK.
11:37, Jan 17, Esther Gabbrielli, NC
It is ridiculous that Lasik is sold as a no risk operation or low risk...piece of cake when many people experience debilitating eye problems afterward. There HAS to be a warning issued regarding the true safety of Lasik. Public health is at risk.
16:02, Jan 17, Name not displayed, KY
My life has been ruined because of lasik. Glasses or contacts can't fix my eyes because of lasik. My eyes are messed up forever. This lasik procedure needs to be stopped now, before more people have their eyes ruined. Lasik surgens are more interested money than telling the truth about how badly lasik can damage your eyes. I have sparklebursts, bad vision in low light and dark, starbursting, double and triple vision, severe glare, halos, light sensitivity, dry eyes, contrast loss, floaters that are worse since lasik. I have been on depression and anxiety medication since right after having lasik over four years ago. Please stop lasik from causing more people lives to be ruined!
06:11, Jan 18, Name not displayed, NC
I have a friend who had to go on disability because of lasik surgery. He and his family have suffered physically, emotionally and economically. The future for them is uncertain at best.
09:17, Jan 19, Mrs. Millie Hershner, NC
My 26 year old son had a retinal detachment in one eye within a month of having lasic surgery. He had retinal reattachment surgery and he now has a permanently scarred retina. There is significant scientific evidence that the suction applied to the eye during lasic surgery can cause a tearing of the retina by pulling on the vitreous humor in the eye.
10:32, Jan 19, Name not displayed, CA
My husband had LASIK in 2006, the suction broke as the laser was making a pass over the cornea, thus destroying it. He has endured years of surgeries as a result, including 2 corneal transplants, not to mention the loss of vision and pain. Our life revolves around this disability now. We have to plan trips carefully and be aware of where we might get help if needed while away from home. Our lives have been totally turned upside down by LASIK.
11:36, Jan 20, Brad Sandona, CA
I had it done two years ago, Severe eye damage, constant pain and PVD's with many eye floaters and guess what, I still need glasses! It is so dangerous, please put an end to it! I will never be the same, it has ruined my life and my wife's life.
12:56, Jan 20, Name not displayed, TX
My colleague who had LASIK surgery 5 years ago is now legally blind. It's ethically wrong for eye surgeons to ruin the lives of perfrctly healthy people just so they can make a few thousand dollars.
19:42, Jan 20, Mr. Nathan Jarnagin, NC
My life has been negatively changed forever. I suffer from chronic dye eye which is physically, emotionally, and financially debilitating. The public needs to be aware of the risks and the hazards associated with this elective surgery.
20:02, Jan 20, Name not displayed, CO
As far as the doctors who sell this surgery are concerned, the potential revenue of this surgery has always eclipsed the community of people who might suffer from it. Do some good science for once on this surgery... make 'em start over
07:49, Jan 24, Mr. Vipin Gupta, United Kingdom
I had thought of lasik 5 years ago and for my son as well later if it went well but after he turned 20. I knew eyes are probably the most important part of our lives and our jobs depend on them. I did a lot of research on the internet at that time and saw many negative comments and I postponed the idea until newer, better machines come up. But reading through all this now I thank God that I took time to make this decision and not go for LASIK. All these doctors are still advertising that it is safe and sound. Where is the greed leading to us? Not being able to drive at night? Not being able to go out in light? Constant dry eyes and pains? Multiple images? What else can they ruin to your life?
