On October 03, 2013, Dr. Oz and Consumer expert Elisabeth Leamy takes a hard look at LASIK Surgery’s Life-Altering Side Effects
LASIK surgery promises to fix imperfect eyesight, but is it safe? Investigative reporter and consumer expert Elisabeth Leamy goes undercover to find out more about the potential life-changing side effects of this popular surgery.
Watch the video! Take a hard look at Dr. Shulman who represents the American Society of Cataract ad Refractive Surgery (ASCRS) - looks a little nervous even with my vision...
Dr. Oz Show 10/03/2013 Investigates - A HARD LOOK AT LASIK!
The American Society of Cataract and Refractive Surgery represents more than 9,000 eye surgeons worldwide. ASCRS treats all concerns about the safety and effectiveness of LASIK very seriously. Based on substantial research and data collected over decades, ASCRS is convinced that LASIK is safe and effective, and offers a viable option for dramatically improving the quality of life for millions of qualified candidates.
LASIK’s safety and effectiveness have been demonstrated in extensive studies conducted repeatedly over the past 20 years, involving thousands of patients and ever-improving technology. Multiple peer-reviewed studies published in medical journals show that more than 95 percent of LASIK patients are satisfied with their results. They also report that for the few patients who experience dry eye and night vision issues, the majority of their side effects resolve over time. Long-term LASIK side effects are extremely rare. ASCRS fully supports additional research to determine why side effects occur and how best to resolve them.
LASIK is surgery, and like all surgeries it involves some risk. In addition, not everyone is a good candidate for LASIK. People considering LASIK should research the procedure thoroughly, choose a qualified, board-certified surgeon, and discuss at length with the surgeon the risks and benefits of LASIK. Patients should work with their doctor to determine whether the procedure is right for them and their lifestyle. ASCRS and other organizations have resources available for anyone considering LASIK to assist in making an informed decision. To learn more about ASCRS please visit www.ASCRS.org.
I'd like to hear the FDA's embellished biased response!
Matt Gelb, Inquirer Staff Writer Posted: Monday, August 26, 2013, 11:01 AM
NEW YORK — History will reflect this was not the greatest of weeks for a man named Casper Wells. There could be an explanation, albeit a frightening one.
Wells was placed on the disabled list Monday morning with what the Phillies described as "vision problems" just two days after he was the losing pitcher and struck out four times in an 18-inning defeat. Interim manager Ryne Sandberg said Wells has played with blurred eyesight.
The Phillies sent Wells to an eye specialist in Philadelphia.
The 28-year-old outfielder had LASIK surgery last November but issues lingered. Sandberg said Wells tried contacts and the prescription goggles. Nothing helped.
"He's also experienced some dry eye in the outfield," Sandberg said. "They dry up when he tries to blink. He tries to blink to gain focus. He's really battling something. It finally got to the point where he didn't feel right about that. He mentioned production and betterment of the team and himself to see if he can get that fixed.
"That is scary. He said oftentimes it was a blurred ball coming in. He didn't know if he was going to blink just right to make it clear."
Wells is 1 for 23 with eight strikeouts and two walks since being acquired by the Phillies on Aug. 8. This is his fifth team of 2013 and the first trip to the disabled list in his career.
Infielder Pete Orr was selected from triple-A Lehigh Valley to replace Wells. Orr, 34, has yet to play in the majors this season. He was hitting .258/.300/.385 with the IronPigs. He will be the 49th different Phillies player in 2013, which ties last year's number with 32 games to play.
If you surf the web, you'll notice that most Lasik websites are advertisements for having Lasik eye surgery. These sites will list complications but severely downplay the risks associated with LASIK just to sell you the procedure. The same can be said of MANY doctors who perform this procedure when you go in for consultation. Don't be rushed, and try to research as much as possible.
This website is to educate you to the dangers of having Lasik when you are not a proper candidate. Before you consider Lasik, you must be sure it can be done safely, and that you are a proper candidate. Many will view this site as anti-lasik, but the intent is to show what can (and HAS happened). The information is here, but it is still YOUR decision!
The experiences of those damaged by LASIK are told because they may be useful to anyone considering Lasik. Most went to doctors who advertised that anyone who was nearsighted, farsighted, or had astigmatism could be done safely...that's almost everybody! They all trusted these doctors, and now, are permanently damaged and in the case of the original owner of this site who is legally blind as a result.
The websites by those damaged contain material which some people do not want you to see, especially in the case of Dom Morgan, Drs. Herbert Nevyas and Anita Nevyas-Wallace. The documents on this site are vast and (also believed) irrefutable however, you are asked that you come to your own conclusions regarding LASIK.
Please be safe - your eyes are too important to risk to just anybody.
> Click Here To View Video Testimony on LASIK, Depression, and Suicide From the April 25th, 2008 Special Hearing of the FDA's Ophthalmic Devices Panel
The psychological impact of a bad refractive surgery can be devastating.
This updated version of the
presentation, prepared by Roger Davis, PhD. Mr. Davis is a Psychologist;
Damaged LASIK patient; Co-author of over 20 articles, chapters, and books in
clinical psychology; and Founder of VisionSimulations.com. He tells of The
Psychological Effects of LASIK Complications.
Submitted to the FDA's Ophthalmic Panel on April 25, 2008, the presentation I
believe is more believable and accurate than what the FDA and refractive
On April 25th, 2008, the FDA help an open public meeting with their Ophthalmic Panel to address 'Quality of Life' issues after Refractive Surgery. Among the presenters were Gerry Dorrian, whose son
commited suicide in 2007 as a result of his complications. Joseph Schnell help up charts depicting his distorted vision.
The 'positive side' was shown as well. The military spoke stating this was one of the best procedures available for those in the field. Doctors brought in patients portraying lasik as a miracle.
The panel was made aware that refractive surgery had a complication rate of about 5%. Think about it: If 1 million people had the procedure done, then that means roughly 50,000 (5%) were damaged! Majority rules though, so 50,000 damaged lasik-induced people doesn't mean anything to the FDA. What about 5 million? That would make 250,000 people with complications! When I hear that the FDA is influenced by financial interest, you get no argument, especially since I've seen how they work!!!
In order "to stop the epidemic of permanent eye injury
caused by lasers and microkeratomes used for LASIK eye surgery". The hopes of
many to ban LASIK altogether may be a far cry from the financially influenced
FDA, but at least a Public Health Advisory should be issued due to the
increasing number of LASIK casualties. The petition can be found HERE, and
There are many websites by refractive surgeons who were
supposed to comply by listing all known risks of LASIK, and haven't. The FDA,
slow as usual, fails to act on their own rules. Your government protection...
Former FDA Chief of Medical Devices, Morris Waxler, PHD, Warns Public About Dangers of
LASIK - Aired February 25th, 2010 on Good Morning America
Leave it to the FDA to deny that they ‘MESSED UP’. Mr. Waxler admitted 10 years after his retirement what most LASIK casualties have been trying to say since the late 1990s. The FDA continues to downplay the risks further allowing more people to get damaged from this procedure - when is enough enough? At least Mr. Waxler has taken his time to actually talk to damaged patients on a personal level (myself included), which is more than I can say for the FDA. I commend Mr. Waxler for his honesty.
Could LASIK Lead to 'Permanent Vision Problems'?
FDA Must Stop 'Epidemic of Permanent Vision Problems,' Former
A former Food and Drug Administration official who helped get the
vision correction surgery LASIK approved back in the 1990s but later spoke out
against the procedure is taking his concerns directly to current regulators at
Morris Waxler, who is now an independent regulatory consultant,
filed a citizens petition today urging the agency to take steps to stop what he
calls "the epidemic of permanent vision problems" caused by LASIK.
Waxler's petition implores the FDA to take actions to crack down
on the procedure, including issuing a public health advisory that warns the
public about the dangers associated with LASIK and implementing stricter
controls over LASIK device manufacturers and practitioners who perform the
In the petition, Waxler included data that he said were evidence
that "LASIK causes persistent vision problems with an overall success rate of
less than 50 percent; a failure rate of more than 50 percent."
Waxler said his change of heart came about after he retired from
the FDA in 2000. He started getting complaints from people who suffered serious
side effects from the procedure, including seeing halos, impaired night vision
and excessive glare.
He was surprised when he looked back at the data presented when
LASIK was undergoing the approval process in the late 1990s.
"When I looked back at that data, there was a tremendous
consistency that show these problems exist in about 18 percent of people who had
LASIK, most of them after I left the FDA," he said.
Some doctors, however, say while they agree with the estimate
that thousands of people have had problems after having LASIK surgery, they
stress that the vast majority of people are very happy after having the
"Ninety-nine percent of people who have had LASIK have excellent
results," said Dr. Robert Cykiert, clinical associate professor of ophthalmology
at NYU Langone Medical Center. "Millions of people have had the procedure done
with a high success rate."
Doctors, Patients Say LASIK Procedure Is
Safe and Effective
One of those satisfied patients is Andy Ng of Long Island,
Ng had LASIK in 2004. He decided to go through with the
procedure because he got tired of spending hundreds of dollars on glasses that
needed special lenses and would get banged up because of his participation in
sports. He also found contact lenses cumbersome and time-consuming.
He said he already knew about the side effects before he went
in for the surgery.
"I knew for a fact I was going to have halos at night," Ng
said. He added that aftewards, the halos didn't make much of a difference for
"I have no other problems, such as floaters, dry eyes, etc.,"
Doctors stress that LASIK is no different from any other
medical or surgical procedure.
"We always would like to have any medical procedure or
surgical procedure that works 100 percent of the time, but that doesn't exist,"
"Complications do happen, but it's rare, and often, we're not
sure why," said Dr. Penny Asbell, professor of ophthalmology at the Mount Sinai
School of Medicine.
Doctors also say that even if a patient is an ideal candidate,
the surgeon is very skilled and the equipment is top-of-the-line, problems can
still occur, so it's difficult to predict whether someone will suffer from LASIK-associated
Communication, Information Vital to
Minimizing LASIK Risk
Not everyone is a candidate for LASIK, and doctors say it's
important for prospective patients to understand that. People with vision that
continues to get worse, extremely poor vision, certain characteristics of the
cornea and some diseases may not be suitable candidates for the procedure.
"Doctors need to take time with a patient and get all the
information they need," Asbell said. "Doctors also need to learn what the
patient's expectations are. If a person wants 20/15 vision, they may not be the
Experts also say there are still things about LASIK that they
just don't know.
"It's very hard to quantify these side effects, such as
determining how to measure how bad things like glare and halos are," Asbell
said. "It's hard to pin down risk factors that differentiate the people who have
problems from the ones that don't so we can try to learn more."
"There are many things we still don't know about the cornea,
such as physiology and variability in structure, so we don't know why some
patients bounce back and others don't," Cykiert said.
Cykiert also said that the thousands of people who have
problems have a legitimate reason to complain to the FDA, and that information
they provide can be helpful for everybody.
"That's how we're going to make the procedure safer and
better," he said.
And that's also how there may eventually be more people like
Andy Ng, who has no complaints about his LASIK experience.
"The procedure is one of the best things out there for the
eyes," he said.
ASCRS President Denies Accusations of Former FDA LASIK Chief
In a scathing three-page letter to R. Doyle Stulting, MD, PhD, president of
the American Society of Cataract and Refractive Sugeons (ASCRS), Morris Waxler,
PhD, the head of the Food and Drug Administration (FDA) branch responsible for
reviewing data on LASIK between 1996 and 2000, accused the ophthalmic
organization of blatantly ignoring several of the risks involved in PRK and
In the letter dated May 7, 2010, Dr. Waxler, who recently said the FDA’s
approval of LASIK devices was a mistake, specifically criticizes a proposed
ASCRS phase 2 keratectasia trial, claiming it is unethical and puts patients at
risk of post-surgical corneal failure, induces corneal thinning and bulging, and
increases the likelihood of other permanent LASIK complications.
“The ASCRS Phase II keratectasia trial proposes doctor-induced (iatrogenic)
injury in vulnerable patients in order to study iatrogenic insult, instead of
mitigating thinning and bulging of the cornea by not performing LASIK and by
determining how to stabilize corneas already damaged by LASIK,” writes Dr.
Waxler, who goes on to say he will do everything he can to block the approval of
such a study.
In support of his claims, Dr. Waxler cites several clinical reports that, among
other statistics, say 15% to 30% of LASIK patients suffer from eye pain, glare,
halos, dry eyes, night vision and other problems, and 1% of LASIK patients have
Dr. Waxler also accuses the FDA of being “complicit with LASIK manufacturers,
ASCRS, and others in minimizing multiple permanent vision complications.” He
asked for Dr. Stulting's cooperation in helping to eliminate unnecessary LASIK
through more transparency about the short-term "wow" effects versus the reality
of permanent eye injury.
In a response letter dated Sept. 20, 2010, Dr. Stulting broadly denies all of
the claims and accusations made by Dr. Waxler, calling his view of LASIK
“misinformed, unsupported by evidence, and lacking in balance and perspective.”
“LASIK was first approved by the FDA on your watch, following all the required
FDA protocols and guidance documents created to measure safety and
effectiveness. In fact, laser vision correction is one of the most studied
elective surgical procedures, with 7,830 patients representing 16,502 eyes in US
FDA clinical trials from 1993 to 2005 – not to mention more recent submissions
to the FDA and thousands of other patients reported in the published
literature. The FDA review process is more stringent than that of any other
country in the world,” he stated.
Addressing Dr. Waxler’s accusation that the ASCRS Phase II keratectasia trial
poses a danger to patients, Dr. Stulting called the assertion “plainly wrong,”
saying Dr. Waxler does not have access to the protocol he references, making it
impossible for him to make a responsible, meaningful comment. “Your negative and
accusatory comments are inappropriate, misleading, and without foundation,” he
Dr. Stulting also said the statistics Dr. Waxler cited were inflated and
inconsistent with existing data. For example, the report that Dr. Waxler’s used
to claim that at least 1% of LASIK patients have keratectasia actually gave the
rate of 0.66%, and even that is the highest estimate in the literature, Dr.
Stulting said. Published estimates of its incidence actually range from 0.0004%
to 0.66%, he said.
Dr. Stulting also accused Dr. Waxler of manipulating data by referencing the
incidence of keratectasia outside of the United States, and on another occasion
referencing the results of LASIK treatments with a laser designed more than 20
years ago that is not commonly used in the United States today.
“In summary, your letter is filled with false statements, incorrect citations of
the published literature, references that do not fairly represent the existing
literature, mischaracterization of a study protocol you have never seen,
incorrect reference to outcomes of PRK as if they were for LASIK, citation of
results for a laser designed two decades ago as if were representative of modern
lasers, mischaracterization of results from older lasers as “better than most,”
reference of a graph that does not exist in the reference you cite, and
misrepresentations of the actual performance of modern excimer lasers for the
correction of refractive errors,” Dr. Stulting said.
Given Dr. Waxler's experience and Dr.
Stulting's influence with industry, I'd be more inclined to believe Dr. Waxler!
Surgery Proponent Questions Safety of Procedure
The quest for 20/20 vision… Millions of people want it and have undergone Lasik
surgery to get it to correct their vision. But the man who was a key proponent
to approve laser eye surgery is now speaking out against it. Former Food and
Drug Administration official Morris Waxler sees things differently now. Waxler
is petitioning the FDA to strengthen warnings and regulations regarding Lasik….
To stop what he calls an “epidemic of permanent vision problems” caused by Lasik.
Waxler says data shows more than 50% of Lasik patients have vision problems,
such as seeing halos and starbursts around lights and objects and blurriness.
Waxler says that 33% of patients end up getting glasses. But not everyone
agrees… and we’ll get both sides of this argument.
This morning, CNN’s Kyra Phillips talked with Morris Waxler and Dr. Stephen
Slade who performed the first Lasik surgery in the U.S.
Dr. Morris Waxler and Dr. Stephen Slade Interviewed on CNN About LASIK Safety
MSNBC Interview of Morris Waxler, PhD, on 2/18/2011
Waxler is the former head of the FDA branch responsible for reviewing the
clinical trial data on LASIK, and played a role in the original review and
approval of LASIK devices. When LASIK was first approved, the FDA relied on
small patient populations and short-term data. Now, based on long-term LASIK
data and new LASIK clinical studies, Dr. Waxler is urging the FDA to withdraw
the approval of LASIK devices due to an unacceptably high adverse event rate,
which he says was withheld from the FDA.
For those that believe the above to be a fallacy, In June, 2012, this study was published:
Invest Ophthalmol Vis Sci. 2012 May 15. [Epub ahead of print]
Fibrinogen, Riboflavin and UVA to Immobilize a Corneal Flap - Conditions for Tissue Adhesion.
Littlechild SL, Brummer GA, Zhang Y, Conrad GW.
SOURCE Division of Biology, Kansas State University, Ackert Hall, Manhattan, Kansas, 66506-4901, United States. Abstract
Purpose: Laser-Assisted In Situ Keratomileus (LASIK) creates a permanent flap that remains non-attached to the underlying laser-modified stroma. This lack of permanent adhesion is a liability. To immobilize a corneal flap, a protocol using fibrinogen, riboflavin, and UVA light (FIB+RF+UVA) was devised to re-adhere the flap to the stroma.
Methods: A model flap was created using rabbit (Oryctolagus cuniculus) and shark (Squalus acanthias) corneas. Solutions containing fibrinogen (FIB) and riboflavin (RF) were applied between corneal strips as glue. Experimental corneas were irradiated with long wavelength (365nm) ultraviolet light (UVA). To quantify adhesive strength between corneal strips, the glue-tissue interface was subjected to a constant force while a digital force gauge recorded peak tension.
Results: In the presence of FIB, substantive non-covalent interactions occur between rabbit corneal strips. Adhesivity is augmented if RF and UVA also are applied, suggesting formation of covalent bonds. Additionally, exposing both sides of rabbit corneas to UVA generates more adhesion than exposure from one side, suggesting that RF in the FIB solution catalyzes formation of covalent bonds at only the interface between stromal molecules and FIB closest to the UVA. In contrast, in the presence of FIB, shark corneal strips interact non-covalently more substantively than those of rabbits, and adhesion is not augmented by applying RF+UVA, from either or both sides. Residual RF can be rinsed away within 1 hour.
Conclusions: Glue solution containing FIB and RF, together with UVA treatment, may aide immobilization of a corneal flap, potentially reducing risk of flap dislodgement.
Bala Cynwyd & Philadelphia, PA and Marlton, New Jersey
My experience with Drs. Herbert Nevyas and Anita Nevyas-Wallace (Nevyas Eye
This section provides information:
Regarding their investigational study (before, during, and after) and what I
believe to include improper use of a laser under an IDE (Investigational Device
Exemption) - Please click the 'Read More' button below.
As noted by several renowned LASIK doctors, the Nevyases Deviation from
Standard of Care;
On their counsel's threats and intimidation to shut down my websites and the legal battle
to retain my free speech rights.
Although the marketing of LASIK focuses on quality of life, informed consent does not. Instead, the real risks are hidden in medical jargon that never mentions their true effects, particularly severe depression and suicidal ideation.
Right now, there are many Lasik casualties worldwide struggling to...
Cope with depression and suicidal ideation, medical disease syndromes not explicitly mentioned on their informed consent.
Cope with the symptoms of post-traumatic stress (PTSD) and other anxiety disorders.
Cope with their surgeons telling them that nothing is wrong with their eyes.
Cope with "second opinions" designed to protect their surgeon from legal problems.
Find a hard contact lens to fit their irregular corneas, often spending thousands and thousands of dollars hunting for a suboptimal solution.
Cope with the possibility of losing their jobs, homes, or spouses because of sudden, permanent visual loss.
Cope with three, four, or five complications at the same time.
One of the key factors I've tried to overcome is how best to accommodate my quality of life since LASIK. Visual aberrations differ from person to person, but I found in my situation the best way to adapt is to simulate daylight, as daylight offers the least complications. There is still a major loss of contrast but in my situation, it's the best I can do.
There are many ways to light your home, from the conventional light bulb to fluorescent and halogen. I found halogen to be the most costly and fluorescent to be somewhat effective. Still not the same as natural daylight. I did purchase a light from a local hydroponics store which proved quite effective, however, it is a 1,000 watt light bulb (ballast required) which did increase my electric bill.
There is a growing number of companies offering lighting simular to natural daylight. One such company, DaylightCompany offers all types of lighting, and in fact states many uses for their lighting especially for those with low vision. I've seen these lights, and I believe they would be beneficial to anyone with visual aberrations.
HD! What a difference! The glare and ghosting are less with this type of TV compared to the older sets. LED, even better!
There ARE alternatives for those who may not want surgery and those with post refractive complications.
As an alternative to not risking your eyes to surgery, Paragon CRT® lenses reshapes your corneas while you sleep!
For those with Post-refractive complications, SynergEyes offers lenses that have been praised by both patients and practitioners.
For more information on these lenses and more, please...
Dr. Edward Boshnick maintains a cutting edge practice devoted to the restoration of vision and comfort lost as a result of refractive eye surgery (including LASIK and Radial Keratotomy), keratoconus, corneal transplant surgery, pellucid marginal degeneration, extreme dry eye, corneal dystrophies, corneal trauma and Stevens-Johnson Syndrome.
Specializing in contact lens care, children's vision, orthokeratology and vision care for the partially sighted (low vision). Dr. Boshnick has been a clinical investigator for both the FDA and several major contact lens manufacturers for over 20 years. Dr. Boshnick has also lectured extensively and authored a number of professional articles dealing with contact and scleral lenses and orthokeratology.
When I first started warning others of the potential risks of LASIK surgery, I could not name Drs. Herbert Nevyas and Anita Nevyas-Wallace (the doctors who damaged my eyes) due to litigation
After my med mal lawsuit, I added the doctors’ names because I believed then (and still do) that as a matter of public safety, they should be named. Their investigational study, as proven by the information (documents) posted resulted in numerous lawsuits. I posted all of the information I could get.
The Nevyases did not like this, and filed a defamation lawsuit against me. In the course of the 2 years it took for this case to appear before a judge at trial, my website was shut down 3 times, through intimidation and threats of lawsuits against my web hosting companies. On the second attempt, even after a temporary restraining order was denied twice by the courts, my site was shut down due to phone calls and a letter from Stein & Silverman, the Nevyases’ attorney, misrepresenting the Philadelphia courts' order.
In July 2005, I was ordered by the court to remove the doctors’ names from my website. I appealed the court's decision.
Were My Rights Being Violated?
In the Nevyas Eye Associates section of this site, I believe the documents posted support all my claims against Drs. Herbert Nevyas and Anita Nevyas-Wallace (Nevyas Eye Associates). The Nevyases have fought hard to keep these documents from the public eye.
Public Citizen felt so strongly about my
rights being violated, that they appealed on my behalf, pro bono (without
charge to me). The ACLU also took interest (they helped me obtain local
counsel for my appeal).
Because Public Citizen does not accept funds from corporations,
professional associations or government agencies, we can remain
independent and follow the truth wherever it may lead. But that means we
depend on the generosity of concerned citizens like you for the resources
to fight on behalf of the public interest.
Public Citizen has done an exceptional job in providing representation
for not only my rights, but those of many others. Please consider
donating to help them continue protecting the rights of Americans. The
donations ARE tax deductible.