FDA Examines Laser Eye Surgery Complaints

Lasik Surgery Patients Report Vision Problems, Including Blurred Vision And Dry Eyes

(AP)  A decade after it first approved devices for laser eye-correcting surgery, the Food and Drug Administration is taking a closer look at grievances from patients, including blurred vision and dry eyes.

An estimated 6 million Americans have undergone Lasik surgery, which permanently reshapes the cornea, a clear layer covering the eye. There are no guarantees of 20/20 vision and the long-term safety of the procedure is still unknown.

But the society of eye surgeons who perform Lasik says 95 percent of patients are satisfied with their results. The group is expected to tell regulators later this week that most side effects from Lasik surgery are rare and temporary.

FDA will hear from Lasik eye surgeons as well as disgruntled patients at a meeting Friday of its outside panel of eye experts.

The agency will ask the expert panel whether educational materials given to patients considering Lasik need to be changed or updated, according to documents posted to the agency's Web site Wednesday.

Regulators agreed to hold the meeting after years of complaints from a small group of patients who say their eyesight has been irreparably damaged by the surgery. The agency received 140 reports of Lasik-related problems between 1998 and 2006, according to an agency spokeswoman.

Dean Kantis, who is scheduled to speak Friday, says his vision has suffered since his Lasik surgery in 1998.

"My life is a blur," Kantis said. "When I look at a computer screen I see two pages; when I look up at the moon, I see three of them."

Double vision, night-vision disturbances and dry eye are among the side effects outlined in literature given to Lasik patients, but Kantis and others say physicians often gloss over the risks.

"Just before the procedure they shove the informed consent form in front of you, but you just sign it and no one reads the fine print," Kantis said.

An FDA spokeswoman pointed out the agency has no authority over how physicians handle patients. Regulators have agreed to work with the American Society of Cataract and Refractive Surgery on a large-scale study of patients' quality of life after surgery.

Investors will be watching Friday's meeting to gauge what impact concerns could have on Lasik laser manufacturers, which include Advanced Medical Optics Inc., Alcon Inc., and Bausch and Lomb.

Analysts already expect Lasik procedures to decline 5 to 15 percent this year as economic conditions make the procedure, which costs between $1,500 and $5,000, less financially feasible for many consumers.

The industry's largest player, Advanced Medical Optics, cut its 2008 earnings outlook earlier this year on the expectation of fewer procedures.

But Wachovia analyst Larry Biegelsen said Friday's FDA meeting could prove beneficial for the industry if it shows patient outcomes are relatively positive.

In a note earlier this month, Biegelsen wrote that a new analysis of 2,200 Lasik patients should provide "a good defense" for companies and physicians. The results, which eye doctors will present Friday, show 95 percent of patients across 19 studies were satisfied with their vision following surgery.

Biegelsen rates Advanced Medical Optics "market perform."

Shares of Advanced Medical Optics Inc. fell 35 cents, or 1.7 percent, to $19.93 Wednesday while Alcon Inc. shares rose $1.74 to $153.30

[lasiksuicide]

Dean Andrew Kantis: (cont''d #4):

I ask this Panel to hold the FDA responsible for reviewing the Ambulatory Code: 21 CFR 803.17 requiring all LASIK facilities since 1997 to report ALL adverse patient outcomes. I feel every LASIK facility in this country is in violation of this mandatory requirement, which should prompt a Class Action Lawsuit. If the CDRH has not even bothered to check the LASIK Centers in their own neighborhood, why did they all of a sudden set up %u201CSight Net%u201D as a new initiative for their own incompetence? I do hope the media here today will investigate this.

Lastly, Number Five: What are the unforeseen Emotional Consequences of LASIK that Effects Every LASIK Doctor, Their Family Members, and Patients? I come today, at my own expense, to inform this Panel that you have a serious problem on your hands of very desperate, suicidal and angered patients that know their LASIK doctors lied to them and blame their doctors for ruining their precious lives. I ask this panel to set up an Emergency Hurt LASIK Patient Fund, in order to help patients with suicidal preventative therapy, ongoing medical expenses, legal representation, and lost wages. Please take immediate action to protect the end consumer who is paying you to protect them.

Thank you.

Sincerely,

Dean Andrew Kantis
www.LifeAfterLasik.com

[lasiksuicide]

Number Three: What constitutes a LASIK %u201CSuccess?%u201D I see double vision, halos, starbursts, fluctuating vision, and dry eye syndrome%u2026Yet, I was told that I was a %u201CSuccess.%u201D Can you believe that? In order to believe the LASIK Industry%u2019s reported satisfaction rate of 95%, you must accept these complications to be %u201Cacceptable normal outcomes.%u201D That''s the question... Do you believe a patient who has these problems to be a %u201CSuccess%u201D because the LASIK industry does! Shouldn%u2019t %u201CPatient Success%u201D be decided by each individual patient however THEY define %u201CSuccess?%u201D How does this Panel define Success?

Number Four: What is a %u201CBreach of the Standard of Care%u201D for LASIK Doctors? The FDA has stated over and over that it is NOT their job to discipline doctors. Then who%u2019s job is it because nobody seems to be doing it? I am out of a life that I once enjoyed because MONEY came first and my Well Being came last! I ask this Panel to hold the FDA responsible for reviewing the Ambulatory Code: 21 CFR 803.17 requiring all LASIK facilities since 1997 to report ALL adverse patient outcomes. I feel every LASIK facility in this country is in violation of this mandatory requirement, which should prompt a Class Action Lawsuit.

[lasiksuicide]

Dean Andrew Kantis: (cont''d #3)

Number One: What is the truth about the FLAP and Pupil Size? I was told that the flap created heals like a cut on your hand. But the truth is the flap NEVER heals, is unpredictable, and leaves the patient with a permanently scarred cornea. My pupils were measured off the charts at 9mm, yet my doctor told me %u201CI was the perfect patient candidate for LASIK.%u201D Just remember: Today%u2019s happy 20/20 LASIK patient may regress and be tomorrow%u2019s LASIK casualty driving a school bus picking up YOUR children. Oh yes, it effects every single one of you here today%u2026

Number Two: What is %u201CTrue Informed Consent%u201D? I have submitted a complete pamphlet to this panel that gives the patient %u201CTrue Informed Consent%u201D with full color pictures illustrating the known side effects. Please consider mandating this pamphlet for yours is antiquated. Then educate the consumer on the Statute of Limitations so they know the %u201Ctimeframe to sue their doctor%u201D starts from the date of the procedure NOT the date of discovery. The Lying LASIK Doctors all know this%u2026

[lasiksuicide]

Dean Andrew Kantis: (cont''d Part 2)

After submitting complaints on these same doctors to the Department of Regulation, backed by solid evidence, I soon found all were DENIED. They all went up to %u201CProbable Cause,%u201D and there at the top sits a Medical Doctor in order to %u201Ccover a fellow doctor.%u201D I feel like I have been RAPED%u2026Where is the FDA?

Because of the Lies, I was unable to sue my doctor before the Statute of Limitations ran out. I guess that is why they all kept telling me that it would take 3, 4 maybe 5 years to fully heal. Sound familiar? I had to go online to find out the truth. I am now out of pocket for all medical costs, lost wages and for daily suffering.

I don%u2019t know of any other procedure where hundreds of patients have created websites, warning the public about the unpredictability and corruption of LASIK surgery. I have outlined (5) KEY Emergency Points which should be thoroughly answered by this Panel, to ensure that the LASIK industry does not continue to DUPE the misinformed public.

[lasiksuicide]

FDA PANEL DISCUSSION POINTS- April 25th, 2008
By Dean Andrew Kantis (#2 Guest Speaker)

Good morning FDA Panel, Honored Guests, and Fellow Victims of the Flawed & Unpredictable LASIK Eye Surgical Procedure. My name is Dean Andrew Kantis, founder of LifeAfterLasik.com. For the past 9 years, I have spent $30,000 seeking restoration of my ruined vision only to find out there is NO CURE. Through my website, hundreds of victims have contacted me expressing their suicidal thoughts. Some have already committed suicide. It%u2019s always the same story. I WAS LIED TO%u2026The name says it all%u2026LA...SICK!

When I began to speak out against LASIK years ago, I encountered a severe backlash. My own doctor, Nick Caro of Saint George in Chicago, tried to sue me for $2 million dollars for exposing his 40+ LAWSUITS. He then caused my family to get a divorce last year by harassing my wife attempting to get her fired from her nursing profession. My family has been harassed, has had death threats, and was lied to by this doctor, yet no one has punished him for his actions%u2026 Where was the FDA?

How is it that a doctor in this country can have 40 lawsuits with NO KNOWN DISCIPLINARY ACTION? I feel that my %u201Csecond opinion%u201D doctors also lied to me, and I know they are the problem. How is a patient ever able to find out they have a problem if all of the %u201Cfollow up%u201D doctors lie to protect the original doctor?

[cberger]

I am a board certified ophthalmologist (cornea specialist) who performs LASIK and PRK. What most refractive surgeons omit telling patients is that refractive surgery changes the curvature and dynamics of the cornea.This makes intraocular pressure monitoring (important in glaucoma diagnosis and treatment) and intraocular lens calculations for cataract surgery difficult.

If the preoperative,operative and postoperative information is available it can be used to better calculate the true intraocular pressure and implant power.

Most refractive surgery patients are in their 20s and 30s but glaucoma and cataracts don''t become problems for decades later. By this time the medical record is lost or unavailable.

There is only one web-based refractive surgery database (SAFEGUARDYOURSIGHT) where patients can store this information for future use.

Whether you use this database or not it is important to obtain your medical record for safekeeping. You will need it one day!

[cberger]

I am a board certified ophthalmologist (cornea specialist) who performs LASIK and PRK. What most refractive surgeons omit telling patients is that refractive surgery changes the curvature and dynamics of the cornea.This makes intraocular pressure monitoring (important in glaucoma diagnosis and treatment) and intraocular lens calculations for cataract surgery difficult.

If the preoperative,operative and postoperative information is available it can be used to better calculate the true intraocular pressure and implant power.

Most refractive surgery patients are in their 20s and 30s but glaucoma and cataracts don''t become problems for decades later. By this time the medical record is lost or unavailable.

There is only one web-based refractive surgery database (SAFEGUARDYOURSIGHT) where patients can store this information for future use.

Whether you use this database or not it is important to obtain your medical record for safekeeping. You will need it one day!

[cbser6]

FYI those of use who have had Cataract surgery are having THE SAME PROBLEMS. Double vision, focus, and headaches have plagued me since my cataract surgery 8 MONTHS ago. Didn''t have the problem before the surgery. And nobody can/will explain why..........Now I face another possible surgery with a eye muscle disorder opthomology doctor. Why can happen next??
And how do I pay for this one??

[brianp55]

I am generally an enthusiast when it comes to technology, but there is no way I''m going to let someone fire a laser into my eyes. There are no guarantees and the consequences for their failure are too great. I am happy to continue wearing my $15.00 Dr. Dean Edels.

[tucano2]

If the FDA approved it the liklihood is that it is unsafe.