This letter was mailed on Monday, September 20, 1999 to the recipients listed and alluded to in the table below.
I used "express mail, return receipt requested" for the letters sent to Donna Shalala, the CEO, and Dr. Alpert.

The FDA and FTC have already issued warnings to the refractive surgery industry regarding the practice of over-stating the benefits and under-stating the risks of refractive surgery. However, based on my own experience and that of others, I don't think the FDA, FTC, and state medical boards have gone far enough in regulating the refractive surgery community. I am aware in excess of a hundred cases of persons with impaired vision following refractive surgery. Since I am one of them, I have some strong feelings about the subject.

Frankly, I don't like having my own eyes turned into a profit center. I also don't like participating in a medical experiment without my knowledge. Normally "they" pay "you" to participate in medical experiments. Based on my experience and considerable reading, I'd say there's another significant problem with this medical experiment, refractive surgery in the United States. In this medical experiment, the results of the experiment are not being tracked, collated, and published.

I think it is important to put both the manufacturers and the regulatory bodies "on notice" regarding the un-reported complications that are resulting from refractive surgery, in the United States and around the world. In other words, the message needs to be sent to the manufacturers that the doctors who "use" their equipment are not performing as learned intermediaries -- in which case, legally, a case can be made that it is the responsibility of the equipment manufacturers to put BIG warning signs on their Laser Ophthalmological Workstations regarding the risks associated with the used of their equipment.

If you have already had refractive surgery, by mailing your ophthalmological medical records to the FDA and State Medical Board, you are helping the regulatory bodies develop a more accurate statistical picture of refractive surgery. I suggest using "certified mail, return receipt requested" because it helps to guarantee that the "message got where it is going."

In fact, the refractive surgeons are NOT filing Medical Device Reports, the proper mechanism for a doctor to report complications involving a piece of equipment to the FDA. If you are a patient with post-laser-surgery-complications, by sending your ophthalmological medical records using "certified mail, return receipt requested" to the appropriate regulatory personnel, you are performing a function similar to the filing of an MDR.

This is not to ignor RK patients -- I'm sure there is a proper form for reporting RK success' and complications. A letter to a regulatory body is a good way to start.

At this point I think the keyword is METRICS -- millions of people around the world have had refractive surgery, but nobody actually knows what the true complication rate is -- or the true benefit rate.

My hunch is that the Surgical Eyes Foundation will take the lead in developing a clear statistical picture of refractive surgery. They might be a good organization to mail your ophthalmological medical records to, also.

Examples of Metrics -- all measurements taken Pre-op AND Post-op ...

Visual Acuity, Measured by Refractive Surgeon.

Visual Acuity, Measured by Independent Eye Doctor -- I say this because I have found there to be quite a difference. My "doctor" (the "surgeon" who performed my LASIK) tells me I'm 20-25 in my right eye, and the HMO Optometrist told me I'm 20-40. In both cases, the measurements were performed using the antique Snellen eye-chart.

Astigmatism
Prism Correction
Contrast Sensitivity
Eyedrop Consumption
Earning Capability

Additional Data ...

Restrictions recommended by Refractive Surgeon regarding Post-op activities, compared to what is known about corneal healing.

E.g. my own "doctor's" staff told me I could go body-surfing a week after the surgery, resulting in my query, "you mean the flap is firmly back in place and partially healed by then ??" and the answer, "Yep", when in fact the flap can be easily lifted by the surgeon WITHOUT A MICROKERATOME during a period of 1-3 months after the surgery. Additionally, endothelial cells are migrating across the transition zone between the flap and the rest of the cornea a year after the time the "flap" is re-positioned.

Finally, I am hearing that the "flap" resulting from the microkeratome cut NEVER FULLY HEALS. I.e., it never "becomes one with the eye" again. Yet, before my own LASIK surgery, I was led to believe -- by a highly-experienced refractive surgeon -- that the flap and cornea do return to a state of integrity and strength like before the surgery.

This is very important to me, because I like to body-surf. And let me tell you, I'd much rather lose a contact lens in a heavy wave than A PIECE OF MY CORNEA !!!

Comparison of complications described in Refractive Surgeon's "Informed Consent" form to complications described in medical journal literature, FDA clinical trials, SEC reports filed by ophthalmic equipment manufacturers, and anecdotal reports published in Internet newsgroups and websites.

Stock owned by Refractive Surgeon in the laser ophthalmological workstation companies and eyedrop companies -- i.e. vested interest of Surgeon in success of Refractive Surgery Industry.

Stock owned by members of Regulatory Bodies in the laser ophthalmological workstation companies and eyedrop companies -- i.e. vested interest of members of Regulatory Bodies in success of Refractive Surgery Industry.

Stock owned by "patient evangelists" in in the laser ophthalmological workstation companies and eyedrop companies.

"M", the patient evangelist who first told me about my "doctor" was MIGHTY evangelical about refractive surgery and Doctor "X". Was "M" trying to save me from the chronic torture of sweat dripping around my eyeglass frames during a yoga class ?? Or did he own stock in one or both of the laser ophthalmological workstation companies ?? Has your stock done well the last few years, "M" ?? I know "M" received a significant discount on the price of his own refractive surgery. Did "Doctor X" coach "M" regarding any of the foregoing ??

Legal Cases, Personal Injury, Pending and Settled, involving Refractive Surgeons and Equipment Manufacturers.

--------------------------------------------------------------------------------

In Summary ...

Again, I think the patients who undergo LASIK, or any refractive surgery, deserve to be FULLY informed about the risks and benefits
BEFORE the procedure.

--------------------------------------------------------------------------------

That said, this is "the letter" -- with some slight alterations made, reflecting contemplations of anonymity.

I am indebted to and wish to acknowledge Ron Link and the other courageous members of the Surgical Eyes community for their support during a challenging time of my life.

--------------------------------------------------------------------------------

Roger * Roger_Superfood@excite.com

Donna E. Shalala Ron Link
Secretary of Health and Human Services Executive Director
U.S. Department of Health & Human Services Surgical Eyes Foundation
200 Independence Ave. S.W. 341 Lafayette Street #169
Washington, D.C. 20201 New York, NY 10012
- -
Mr. "Z" Al Gore
Chief Executive Officer Vice President of the United States
1600 Pennsylvania Ave.
Washington, D.C. 20500
- -
Dr. Susan Alpert William Jefferson Clinton
Director, Office of Device Evaluation The President of the United States of America
Food & Drug Administration 1600 Pennsylvania Ave.
U.S. Department of Health & Human Services Washington, D.C. 20500
200 Independence Ave. S.W. -
Washington, D.C. 20201 -
- -
Hon. Senator Edward M. Kennedy Mrs. Hillary Rodham Clinton
315 Russell Senate Office Building c/o The President of the United States of America
United States Senate 1600 Pennsylvania Ave.
Washington, DC 20510 Washington, D.C. 20500
- -
Mrs. Tipper Gore -
c/o Vice President of the United States -
1600 Pennsylvania Ave. -
Washington, D.C. 20500 September 19, 1999
-


Ladies and Gentlemen:

I am writing regarding a subject of great mutual interest.

The general subject is the miracles and supposed miracles of modern medical technology. The
specific subject is LASIK, Laser Assisted In-Situ Keratomileusis.

I am a LASIK patient. My own LASIK surgery was performed on both eyes on August 14, 1998 by Dr. "X" at the in , California.

I queried one of Dr. "X's" assistants about what machine was used during my surgery. The answer I remember receiving is a "Machine Y."

Since that time, my life has been a nightmare of pain (in my left eye) & esotropia (in my left eye). The esotropia results in double vision, and the foreign body sensation is akin to a dirty contact lens permanently implanted on (stuck to) the cornea of my left eye. The esotropia was diagnosed about 3 months after the surgery. The foreign-body sensation in my left eye has been a permanent fixture in my life since the time of the operation.

Also accompanying these symptoms has been the loss of clear eagle-eyed near-sighted vision. The Doctor spoke a lot about presbyopia during pre-op consultations. It appears to me that LASIK "burns away" your near-sighted vision and that the symptoms are similar to presbyopia. Strange that my own personal symptoms of presbyopia should emerge immediately after the LASIK procedure.

In terms of day to day living, I was shocked to find that I couldn't read the big block letters at the opening of the recent Phantom Menace movie, without closing one eye. I recall seeing "Return of the Jedi" in 1983 when I was wearing glasses, and having no such problems. This is an example of the double vision at work, and my frequent remedy -- to close one eye.

Whether you call it "loss of eagle-eyed near-sighted vision" or "sudden onset of presbyopia symptoms immediately following LASIK procedure", there is another example which brings it home regarding the aspect of my vision that I have lost. Before the LASIK I had about 28 years of metal-working experience. I could look at an 0-80 screw, the size you might use in a watch case, and clearly see the fine detail of the helical threads. A situation arose at work recently where I needed to make a quick modification on a part in a lathe. This involves guiding the head of a carbide tool safely to within .001 inch of a given destination. I had to let someone else do the work.

Whether focussing on the threads of a small shoulder screw or using a carbide tool to increase the length of the shoulder, before the LASIK operation these were pleasurable tasks, involving the ability to focus effortlessly on very small objects. I no longer have that ability.

I call this loss of near-sighted vision, permanent foreign-body sensation, and double-vision an impairment of vision. I am hungry for answers.

I have enclosed color copies of three photos. One photo shows 20 weeks worth of eyedrops. I have a persistent foreign body sensation in my left eye that has not subsided since the surgery. Every time I put in eyedrops, it provides brief, fleeting relief, and then a return to the dual challenge of blepharitis and dry eye syndrome, with which I have been recently diagnosed by the doctors at my HMO.

The strange thing is, before the surgery, I never used eyedrops, except when I was experimenting with contact lens'. I think it is safe to say that I was contact lens intolerant. Therefore, I stuck with my eyeglasses. Then, I met Dr. "X", and I got the impression that I could see clearly without glasses, with no immediate loss in near-sighted vision, without pain, as safely as having a cavity filled at a dentist.

It is my understanding of product liability law that there exists a rule known as the "learned intermediary rule." i.e., though a machine such as the "Y" could be said to have two users, the doctor and the patient, the manufacturer of the machine is considered by the law to have one user -- the doctor. It is incumbent upon the doctor to explain the risks associated with the medical procedure to the patient.

It is my suspicion that the word "learned" also carries with it the essence of integrity.

Perhaps you can help me. Did the operation performed by Dr. "X" using cause my ocular surface disease to manifest ?? It appears to me that the operation has had this effect.

Although I have spent perhaps 3 hours in Dr. "X's" company over two years, I can not recall any time when he has acknowledged that I have blepharitis. However, after five minutes with two different HMO ophthalmologists, I have been told the same thing ... "You have blepharitis." Is it possible that caused my blepharitis ?? Did it exist pre-operatively ... is it possible that Dr. "X" neglected to diagnose and disclose it ??

Based on my contact lens intolerance prior to the LASIK procedure, and the quickness of the HMO doctors to diagnose this condition, I conclude that I had ocular surface disease before the procedure, but was asymptomatic, except when I tried to wear contact lens'. Then, I underwent the LASIK procedure, and the symptoms manifested assertively in my left eye.

I am afraid a similar scenario may have occurred relative to my esotropia. My Mom, who took the enclosed photo-with-eyeglasses in 1997, recently took one look at it and said, "yes, you're a little cross-eyed in this photo." What do you think ?? Do you think the LASIK procedure caused my esotropia to manifest, or that it existed pre-operatively ?? I understand that conventional eyeglass' contain a limited prism correction. Is it possible that my esotropia pre-existed the LASIK operation, that it was not diagnosed and disclosed, and that the primary symptom of the esotropia -- double-vision -- manifested only after the operation, when my eyes were functioning without the prosthetic aid of eyeglasses ??

Of course, before the LASIK, my right eye was my dominant eye. After the LASIK, my slightly-crossed left eye has the better visual acuity. Perhaps this shift of visual acuity away from the dominant eye is an important factor in my vision complications.

In any case, I note two references to "strabismus" in the FDA literature. On page 178 of the Second Day of the Ophthalmic Devices Panel convened on October 21, 1997, there is a fascinating exchange between Drs. Stulting and Macsai ...

Dr. Stulting: Well, they don't have it. They have latent strabismus. They have --
Dr. Macsai: But this is fine. They are at risk for developing strabismus if you treat them.

The URL for this section of the Proceedings is ... http://www.fda.gov/ohrms/dockets/ac/97/transcpt/3344t2.pdf
Note ... it is in Adobe Acrobat file format.

Well, if LASIK can cause strabismus, I think it's time to get the word out.

Contrastingly, in a paper entitled, "Discussion Points for Expansion of the "Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers" Draft Document", on page 7 there is an Examination Schedule and list of Exclusion Criteria. Down at the bottom of the table is a row entitled "Subjects at risk for developing strabismus posttreatment." For persons with "Low to Moderate" and "High" Myopia, with and without astigmatism -- I would characterize myself as being moderately myopic with minimal astigmatism pre-op -- the box is checked NA, for Not Applicable. The URL for this paper is ... http://www.fda.gov/cdrh/ode/rslaschk.html

Based on my own experience, the Stulting/Macsai interchange, and the experience of "Phil", who has experienced bi-lateral strabismus following multiple laser ablations, I think that box on that page of the Checklist should have a "Check" for "Applicable", not NA.

In other words, the evidence suggests that ocular muscle dysfunction is an occasional side effect of laser corneal ablation, and the public -- the consumers -- deserve to know this.

I suggest that it is both wise and ethical for the manufacturers of ophthalmic laser workstations to put BIG warning labels on their workstations, describing all risks alliterated to in the medical literature, the FDA clinical trials, the SEC filings, and the Surgical Eyes website. If a doctor as experienced in refractive surgery as Doctor "X" can have patients with the results I am experiencing, then ... I don't know what to say.

Hitherto, the medical suggestions that I have received have been two-fold: to help me deal with the foreign-body sensation (pain) in my left eye following the LASIK surgery, and to help correct the esotropia in my left eye. For the former, it has been recommended that I consider wearing a transparent shield over my left eye, to increase the humidity. And/or buy a humidifier, and/or move to Florida.

For the latter, eyeglasses with a prism correction are apparently a logical avenue to explore. The one pair that I have had prepared thus far, specifically for near-sighted vision to get me back to being a 12-hour-a-day computer nerd, did not achieve the objective. It was more fatiguing than the eye-patch that I now use to achieve clear vision.

In fact, in 1990 I worked for 3 months as an engineering consultant for , with a team of about 60 technical contributors charged with the task of developing an ophthalmological surgical workstation. My responsibilities included the finite element modelling and analysis of the optics for resonances, and the 3D modelling of a device used to measure corneal topography. I was laid off a month before what I guess to be their final "downsizing."

Before my LASIK surgery, I was a bonafide 12-hour-a-day computer nerd. Now, after 7 hours on the computer, my eyes and brain are fatigued. This is not satisfactory.

I am 41 years old.

I presently have a very strong need to understand what has happened to my vision. You are more than welcome to contact me at .

I have enclosed copies of my medical records, as recorded by Dr. "X", along with recent color topographical charts. If you can suggest a doctor who can help me understand what has happened to my vision, I welcome the suggestion. I do not relish the idea of wearing a transparent goggle with prism correction over my left eye for the rest of my life.

Anything you can do to help me develop a clear picture of what has happened to my vision is most appreciated.

Yours truly,
Most Sincerely,

Roger