Saturday, August 31, 2013

Another Pro Athlete Finds His Life Turned UPSIDE DOWN FROM LASIK!


"An elective and irreversible eye reshaping dry eye inducing procedure that wasn't even needed in the first place!"


"LASIK Vision Problems Send Pro Baseball Player Casper Wells to DL"
-LASIK Disability List-)


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.

Read more at:

Question:  "Will you not heed this warning, risk your job, your current normal life, your marriage and ability to drive your kids to school or drive at night, all because a commissioned staffer and desperate LASIK madman/madwoman needing to make $5,000 off of you in 10 flat minutes, tells you that you will love it and to trust them with your only healthy eyes?"  You've been warned...

Friday, August 9, 2013


My Personal Thoughts:
August, 2013 By
Perry Rosenthal, M.D.
Assistant Harvard Professor of Ophthalmology  
Imagine a surgical procedure being performed for cosmetic reasons and patient convenience on a healthy organ critical to our ability to function. Considering that this surgery neither treats nor prevents disease, what is the acceptable rate of serious and permanent complications? Shouldn't it be zero? How can we even consider a rate greater than those of vaccinations that, while also given to healthy people, provide invaluable disease-prevention benefits? LASIK/PRK laser surgeries do not.
How has it been possible that disastrous permanent complications of these surgeries have been ignored by the FDA? In this context, I have a confession to make. Despite my being aware of the many blinding complications of this surgery, having treated many of these patients at the Boston Foundation for Sight (which I founded), like my colleagues, I failed to act on my observations that a surgical procedure performed for non-medical reasons and that has been proven to have disastrous consequences in some, would be sanctioned by the FDA.
I did nothing until I became aware of a complication that had not been previously reported; suicide-provoking pain that is long-lasting and probably life-long. Why had this devastating complication not been reported in the past? I assumed that eye doctors had been misled because these eyes typically look normal and well healed. Moreover, we have been trained to believe that the cause of chronic eye pain can always be identified during traditional examinations and that if nothing is found to explain it, the pain must exist only in the minds of these patients. Moreover, as I discovered, the onset of this type of pain often occurs years after the surgery and their connection is easily dismissed. I thought that these factors probably accounted for its having being overlooked. I was wrong.
I did detailed examinations on 21 such patients and wrote a paper detailing the characteristics of this pain disease (corneal neuropathic centralized pain) in this group in which I explained why it differs from typical temporary post operative pain. I offered my theory about its mechanisms and included suggestions on how it might be possibly prevented or reduced. 
As I began to read the history of LASIK and its complications    
I became aware of the central role of the FDA in sanctioning these procedures.  However, a cursory look at the results of search engines provided a day's read. Where is the shame?
So I sent my paper to the FDA as documentation of this previously unreported complication despite
being warned that they will not respond. I didn't believe it.
I was wrong. I sent it twice without the courtesy of an acknowledgement. Of course they could always say that the paper has no standing because it was rejected.
I would never have imagined that editors of scientific peer-reviewed journals, a for profit manufacturing/marketing industry and, in some cases, even practicing doctors would collaborate to hide these complications from the public and prospective patients. And what about the government agency whose primary responsibility is to protect the public (FDA/CDRH)?  and more than 28 million have been done world-wide. And it was predicted that at the current rate of 800,000 procedures per year, the available pool of surgical candidates is growing by 2 million eyes per year:  
This is a huge industry with tentacles that reach the FDA. In the meantime, think about what will be happening
to many of the people who will be undergoing these
procedures ignorant of their possible life-destroying complications.  This paper was summarily rejected by a
leading peer-reviewed journal in ophthalmology. I shrugged my shoulders and submitted it to one that specializes in corneal laser procedures, fully expecting it to be accepted.  
It too was rejected outright. The reviewers' criticisms were impossible to address.

"Because of the infrequency of this complication, it would
take more than 15 years at an incredible cost to perform the studies they insisted would be needed by other journals.
(They stated that they had no interest in looking at it again.) In other words their suggestions were totally unrealistic.  
I was confused. So I sent the paper to world-class pain researchers for their opinions. All supported its being published. (One called my work "transformative".) Notably, both journals ignored my suggestion that at least one of the reviewers be an expert in pain. I began to wonder if they had a hidden agenda. Was I becoming paranoid? I have been accused as having an over-abundance of naivety. 
But I can no longer be silent..."
Perry Rosenthal, MD
Assistant Harvard Professor of Ophthalmology



Thursday, August 1, 2013

Is Steven Schallhorn Using The Navy/DoD To "COOK" The Ongoing LASIK Safety Studies & How Did He Get His Femtosecond LASIK Laser To Market Without FDA Approval?

Are ASCRS's Very Own Steven Schallhorn Abusing The Navy/DoD To Possibly "Cook" The LASIK Quality of Life Safety Studies?
What Is Steven Schallhorn's Financial Interests & Involvement On The Board of Optical Express LASIK Mill?
What Are Steven Schallhorn's Financial Interests/Ownership in the Non-FDA Approved Femtosecond LASIK Laser...

First, lets listen to Schallhorn's paid testimony at the Emergency Opthalmic LASIK Device Panel in DC on April 25th, 2008:
Steven Schallhorn's Ties to Navy Ophthalmologist and DoD (Department of Defense): (they are handling the LASIK quality of life study shown here, again, before the study has even begun, they are boasting a 95.4% patient satisfaction rate and that it will prove LASIK to be safe and effective)

The Department of Defense and Navy are covering all of this up.  They control the fabricated studies, and then report back to the FDA that LASIK is safe.  They try to back it up using “navy and army guys in the field of battle and in “live or die” “intense situations,” which of course they will do better than having to wear contacts or glasses!  But you can’t compare that to daily, un battle like situations behind a desk, on the computer, driving a car, as eye pain post surgery is “UNACCECPTABLE”  etc… 
Below is a timeline, showing a huge “medical cover-up” with a $45 Million dollar DOD contract on Intralase:  “the laser that never had any clinical studies, yet Dr. Steven Schallhorn, who has financial interests in AMO parent company, owns an interest in the company that received a lot of these profits, one month after he resigned from the DOD…”  This is corrupt!  Now the Navy is urging “happy patients” to go online and issue “happy” comments here:
For clarification, very few people ever submit a comments to the LASIK docket on .  It's not like MedWatch reports on the FDA’s website.  When you have 15 submissions on the LASIK docket from one source, that sticks out like a sore thumb.   And that source just happens to be the Navy, who is supposed to conduct an investigation of LASIK for the FDA?.... Here is what Sargeant Scott Barnes said at the FDA Panel I spoke at:
Look at this, here it is all spelled out, for you to see the blueprint unfold:
 On March 10, 2008 an online publication of the America Society of Cataract and Refractive Surgery (ASCRS) reported:
“In a ground breaking interaction, the U.S. Food and Drug Administration (FDA), approached the American Society of Cataract and Refractive Surgery (ASCRS) in the fall of 2006 for guidance in designing a study to that would identify extremely dissatisfied post-LASIK patients, define their significant symptoms, and the impact of those symptoms on quality of life.”
On March 17, 2008, the America Academy of Ophthalmology (AAO) issued a press release announcing, “Organized Ophthalmology and Government Agencies Discuss Study Design for Dissatisfied LASIK Patient Clinical Trial”.
On April 7, 2008, ASCRS issued a similar press release:
On April 24, 2008, quoted Daniel Schultz, then-director of FDA’s Center for Devices and Radiological Health (CDRH), as saying that the LASIK study involving organized ophthalmology would begin no later than 2009:
“The Food and Drug Administration, working with doctors' groups and the National Eye Institute, plans to study how Lasik affects patients' quality of life no later than next year, Daniel Schultz, head of the agency's medical devices center, said today. Identifying why complications occur will help those considering Lasik make more educated choices, he said.”
On April 25, 2008, the FDA held a public meeting of the Ophthalmic Devices advisory panel to discuss post-marketing experience with LASIK. LASIK patients, family members of LASIK patients, physicians, psychologists, and optometrists spoke about the high incidence of LASIK complications and the emotional toll that a bad outcome from LASIK takes on patients.  Several LASIK-related suicides and suicide attempts were reported at the meeting. Organized ophthalmology representatives and active-duty and retired Navy and Army physicians gave testimony asserting that LASIK is safe and effective, and denied any connection between a bad outcome from LASIK and depression.
At the public hearing, Dr. Jennifer Morse, ASCRS consultant and former Navy Program Director for Psychiatry in San Diego, talked about the benefits of LASIK in military and civilian populations, and asserted that there is no scientific evidence of any direct link between LASIK and depression or suicide. Several months later at an AAO annual meeting, Dr. Morse spoke about dissatisfied LASIK patients, saying there must be some neurologic disconnect between what their eyes are seeing and what their brain is processing.

ASCRS paid Dr. Morse’s travel expenses to attend the hearing. 
LASIK surgeon, Dr. Steve Schallhorn who retired from the Navy in early 2007, also spoke at the April, 2008 FDA hearing. Dr. Schallhorn is a paid medical malpractice defense expert witness, has made public statements and published literature denying connection between a poor LASIK outcome and diminished quality of life, and is currently medical director of one of the largest corporate providers of LASIK in the world. Said Schallhorn:
“While in the Navy, I founded the Department of Defense Refractive Surgery Program and directed the Navy program since its inception in 1993… For disclosures, I currently [sic] as a consultant to AMO, a company that markets an excimer laser… LASIK is safe and effective… Patient satisfaction after LASIK is excellent, higher than that reported for other forms of elective surgery.”
On April 8, 2008, just prior to the FDA hearing, Dr. Schallhorn was quoted in OSN Supersite online saying:
"I think it's important that there's an appreciation that what we're talking about here is not the safety and effectiveness of LASIK. That has never been an issue.”
Dr. Schallhorn was quoted in a December, 2009 article in the Journal of the American Medical Association (JAMA) asserting that the FDA LASIK study will find that LASIK is safe and effective and improves patients’ quality of life. 
Steven C. Schallhorn, MD, chairman of the Optical Express International Medical Advisory Board, said he is confident that once the quality-of-life issues are studied, LASIK will be shown to be even more safe and effective. Schallhorn, who is currently a consultant to 2 LASIK companies, bases his opinion on his prior work as a captain in the Navy… "But in the context of the military and looking at issues of quality of life and the impact LASIK has, it is not only a life-changing event, but a performance-enhancing procedure," Schallhorn said. "The FDA study will come tothe same conclusion," he predicted.
 Wow...imagine that!
Source: Mitka M. FDA focuses on quality-of-life issues for patients following LASIK surgery. JAMA. 2009 Dec 9;302(22):2420, 2422.
Interestingly, in December 2006, approximately one month before Dr. Schallhorn’s retirement from the Navy, IntraLase announced that the Department of Defense had awarded the company a $45 million, 5-year contract to supply its FS femtosecond (LASIK flap maker) lasers to the U.S. Army, Navy, Air Force, Marine Corps and federal civilian agencies.  
Dr. Schallhorn has ties to AMO, the parent company of IntraLase (see Exhibit 1).
A third Navy physician, David J. Tanzer, M.D., Program Director of the Navy Refractive Surgery Program in San Diego, was an invited guest speaker at the April, 2008 FDA hearing.  Dr. Tanzer asserted that LASIK is safer than contact lenses. Dr. Tanzer emphasized the success and operational benefits of LASIK in the military, and reported that satisfaction is high. Dr. Tanzer is co-author of a February 2009 peer-reviewed study with Dr. Morse and Dr. Schallhorn which states that patients who are depressed before LASIK are more likely to be dissatisfied with their vision after LASIK. Dr. Tanzer has published several papers with Dr. Schallhorn, all favorable to LASIK. TLC Laser Eye Centers, a large corporate provider of LASIK, lists Dr. Tanzer among its LASIK surgeons on the company’s website.   
Also appearing at the April, 2008 FDA hearing was Lt. Col. Scott Barnes, MD, an Army eye surgeon, who made an impassioned plea on behalf of soldiers at Fort Bragg in North Carolina: 
 "Please don't take [LASIK] away from us."
However, Lt. Col. Scott Barnes, MD coauthored an article in the July, 2008 issue of Current Opinion in Ophthalmology, which apparently contradicts his FDA testimony:  
"At Fort Bragg, North Carolina, the Army surgeons have moved [from LASIK]  to 100% surface ablation in the past 2 years; the five known traumatic flap dislocations (out of 2500 procedures) due to 'typical' soldier activities contributed to this change but not as much as an analysis of the visual outcomes."
Obviously, Lt. Col. Scott Barnes was already aware of the potential for traumatic flap dislocation and poorer visual outcomes with LASIK eye surgery when he testified.
In April, 2009, ASCRS held its annual convention in San Francisco. At the convention, LASIK surgeons performed skits making fun of suicidal LASIK patients. One skit poked fun at patients who complain of halos and glare after refractive surgery.  Another skit featured Dr. Parag Majmudar as "Dr. I. M. Suicidal" singing of "pushing the boundaries of ethics". The skits were published on YouTube by Dr. Majmudar.
In May 2009, Scott Tolchin, a LASIK patient advocate, sent a letter to members of the U.S. House of Representatives Committee on Energy and Commerce and Subcommittee on Oversight and Investigations and others members of Congress seeking an immediate moratorium on the use of excimer lasers for LASIK surgery based on an approximate 20 percent incidence of complications, including dry eyes and night vision problems, reported by patients in FDA LASIK clinical trials. The letter states, in part: 
The FDA announced that further study of LASIK dissatisfaction was needed and reported that it had formed an unprecedented partnership with LASIK professional groups to conduct a prospective LASIK study to begin in 2009. The proposed study amounts to putting the fox in charge of the hen house. Surgeons selected to lead the study include those with direct ties to LASIK device manufactures - a clear conflict of interest.
On October 15, 2009, the FDA announced that it had launched a collaborative study with the National Eye Institute (NEI) and the Department of Defense to examine the potential impact on quality of life from LASIK.
“Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center at Naval Medical Center San Diego.”
The FDA did not, however, explain the sudden departure of ‘organized ophthalmology’ from the proposed LASIK study. 
In November 2009, the FDA reopened a public docket to continue to receive public comments to assist the agency in identifying ways in which it can improve its public outreach efforts regarding the safety and effectiveness of LASIK devices.  Recently, many of the positive comments about LASIK have been submitted by military LASIK patients at the direction of Navy LASIK surgeons in an obvious attempt to slant the FDA's LASIK investigation findings.  
In light of the financial conflicts of interest and bias exhibited by current and former Department of Defense physicians, and tainting of the public docket, the FDA should remove the Navy from phase 2 of the proposed LASIK study. 
To date, the FDA has not explained the 3-plus year delay (from the time it approached ASCRS) in investigating LASIK dissatisfaction.  Although new safety concerns have been raised, LASIK continues to be performed unabated in direct conflict with FDA’s mission to protect the American public from unsafe medical devices.  Considering the elective nature of LASIK and the fact that LASIK carries significant risk to patients’ vital sense of sight, this is unacceptable. 

In December 2006, approximately one month before Dr. Schallhorn’s retirement from the Navy, IntraLase announced that the Department of Defense had awarded the company a $45 million, 5-year contract to supply its FS femtosecond (LASIK flap maker) lasers to the U.S. Army, Navy, Air Force, Marine Corps and federal civilian agencies.
In January 2007, announced that IntraLase was acquired by Advanced Medical Optics (AMO).
In June 2007, EyeWorld magazine reported that Dr. Schallhorn was a consultant for Advanced Medical Optics (AMO), parent company of IntraLase.
In November 2007, EyeWorld magazine reported that Dr. Schallhorn had financial interests with Advanced Medical Optics.
Dr. Schallhorn's daughter, Erin Schallhorn, was employed by AMO at the time the defense contract was awarded.
The article at the following link states that Erin Schallhorn is the daughter of Dr. Steve Schallhorn:

Mention of the infamous Steven Schallhorn (many opinions say he controlled a lot of the LASIK studies and possibly falsified or doctored them up while in the Navy and made a fortune from the Intralase Femtosecond laser which really never went through any FDA Approvals, somehow side stepped the FDA approval/trials process) below…
1.     Originally Posted by cdmike112
I had CustomVue PRK on Nov. 20th 2008. I am currently just under 5 months post op, 20/15 in both eyes but still experienceing some starbursting. It has slowly gotten better over the past month. I was wondering what other peoples experience has been and how long it took for their starbursting to deminish.
Originally Posted by eddie
Don't tell anyone. Wait awhile.
1.     Originally Posted by spitfiremkxiv
To quote a Navy doc during my recent eye exam:
"Statistics show that pilots and applicants experience very few PRK complications compared to the rest of the population."
Don't be the abnormal applicant that has starbursts.
“Interesting is not exactly the word I used.”

“The bottom line is that unless the starbursts are ridiculously bad, they will not be detected in an eye exam -- it is almost completely subjective. It is also almost completely disqualifying.”

“As a little side note, the former head of Navy Refractive Surgery, (
Steven Schallhorn
) who developed the Refractive Surgery program for the Navy and Air Force was an F-14 pilot before going to med school (TOPGUN Instructor, highest score ever recorded in a scored ACM exercise at the annual F-14 fighter derby, real underachiever). He claims that he had horrible starbursts and actually thought it was normal before he became an ophthalmologist.”

“One of the most significant indicators or starbursts and glare is pupil size vs. treatment zone size. Do you know the size of your fully dilated pupil and the size of the area of your cornea that was treated (it should be on your surgical records)? The other common indicators are bad surgeons and bad luck.”