\par
| The Lunch-time LASIK Seminar | \par \parLetter to the FDA | \par \parExcerpts_A_1994 to 2000 | \par \parExcerpts_B_2000 to 1994 | \par \parTHE Common Sense Article | \par \parDepartment of Defense Study | \par
Note: Looking for answers, I sent this letter to the FDA in September\par 1999. I changed the phone number to be current. The formatting\par is a result of my lack of eye time ... I am transposing the letter from\par "Word" format to html.\par
Otherwise the letter is pretty much "original", as it was sent, way\par back when.\par
Roger Bratt\par
Jan. 26, 2002\par
Letter to the United States FDA about LASIK Complications\par
\par
Roger E. Bratt * 1042-B N. El Camino Real, PMB #217 \par
* Encinitas, CA 92024-1322 * Roger_Superfood@excite.com\par
\par
Donna E. Shalala____________________________Ron Link\par
Secretary of Health and Human Services__________Executive Director\par
U.S. Department of Health & Human Services______Surgical Eyes Foundation\par
200 Independence Ave. S.W.__________________341 Lafayette Street #169\par
Washington, D.C. 20201______________________New York, NY 10012\par
\par
Mr. Robert Palmisano________________________Al Gore\par
Chief Executive Officer_______________________Vice President of the\par
United States\par
Summit Technology__________________________1600 Pennsylvania Ave.\par
21 Hickory Drive____________________________Washington, D.C. 20500\par
Waltham, MA 02451_________________________vice.president@whitehouse.gov\par
Dr. Susan Alpert____________________________William Jefferson Clinton\par
Director, Office of Device Evaluation_____________The President of\par
the United States of America\par
Food & Drug Administration___________________1600 Pennsylvania\par
Ave.\par
U.S. Department of Health & Human Services______Washington, D.C.\par
20500\par
200 Independence Ave. S.W.__________________ president@whitehouse.gov\par
Washington, D.C. 20201\par
Hon. Senator Edward M. Kennedy_______________Mrs. Hillary Rodham Clinton\par
315 Russell Senate Office Building________________c/o The President\par
of the United States of America\par
United States Senate__________________________1600 Pennsylvania Ave.\par
Washington, DC 20510________________________Washington, D.C. 20500\par
senator@kennedy.senate.gov____________________first.lady@whitehouse.gov\par
Mrs. Tipper Gore\par
c/o Vice President of the United States\par
1600 Pennsylvania Ave.\par
Washington, D.C. 20500\par
mrs.gore@whitehouse.gov_________________________________________September\par
19, 1999\par
\par
Ladies and Gentlemen:\par
I am writing regarding a subject of great mutual interest.\par
The general subject is the miracles and supposed miracles of modern\par
medical technology. The\par
specific subject is LASIK, Laser Assisted In-Situ Keratomileusis.\par
I am a LASIK patient. My own LASIK surgery was performed on both\par eyes on August 14, 1998 by Dr. Michael Gordon at the Vision Surgery &\par \par Laser Center in San Diego, California.\par
I queried one of Dr. Gordon's assistants about what machine was used\par during my surgery. The answer I remember receiving is a "Summit Apex\par Plus."\par
Since that time, my life has been a nightmare of pain (in my left eye)\par & esotropia (in my left eye). The esotropia results in double\par vision, and the foreign body sensation is akin to a dirty contact lens\par permanently implanted on (stuck to) the cornea of my left eye. The\par esotropia was diagnosed about 3 months after the surgery. The foreign-body\par sensation in my left eye has been a permanent fixture in my life since\par the time of the operation.\par
Also accompanying these symptoms has been the loss of clear eagle-eyed\par near-sighted vision. The Doctor spoke a lot about presbyopia during\par pre-op consultations. It appears to me that LASIK "burns away" your\par near-sighted vision and that the symptoms are similar to presbyopia. \par Strange that my own personal symptoms of presbyopia should emerge immediately\par after the LASIK procedure.\par
In terms of day to day living, I was shocked to find that I couldn't\par read the big block letters at the opening of the recent Phantom Menace\par movie, without closing one eye. I recall seeing "Return of the Jedi"\par in 1983 when I was wearing glasses, and having no such problems. \par This is an example of the double vision at work, and my frequent remedy\par -- to close one eye.\par
Whether you call it "loss of eagle-eyed near-sighted vision" or "sudden\par onset of presbyopia symptoms immediately following LASIK procedure", there\par is another example which brings it home regarding the aspect of my vision\par that I have lost. Before the LASIK I had about 28 years of metal-working\par experience. I could look at an 0-80 screw, the size you might use\par in a watch case, and clearly see the fine detail of the helical threads. \par A situation arose at work recently where I needed to make a quick modification\par on a part in a lathe. This involves guiding the head of a carbide\par tool safely to within .001 inch of a given destination. I had to\par let someone else do the work.\par
Whether focussing on the threads of a small shoulder screw or using\par a carbide tool to increase the length of the shoulder, before the LASIK\par operation these were pleasurable tasks, involving the ability to focus\par effortlessly on very small objects. I no longer have that ability.\par
I call this loss of near-sighted vision, permanent foreign-body sensation,\par and double-vision an impairment of vision. I am hungry for answers.\par
I have enclosed color copies of three photos. One photo shows\par 20 weeks worth of eyedrops. I have a persistent foreign body sensation\par in my left eye that has not subsided since the surgery. Every time\par I put in eyedrops, it provides brief, fleeting relief, and then a return\par to the dual challenge of blepharitis and dry eye syndrome, with which I\par have been recently diagnosed by the doctors at my HMO.\par
The strange thing is, before the surgery, I never used eyedrops, except\par when I was experimenting with contact lens'. I think it is safe to\par say that I was contact lens intolerant. Therefore, I stuck with my\par eyeglasses. Then, I met Dr. Gordon, and I got the impression that\par I could see clearly without glasses, with no immediate loss in near-sighted\par vision, without pain, as safely as having a cavity filled at a dentist.\par
It is my understanding of product liability law that there exists a\par rule known as the "learned intermediary rule." i.e., though a machine\par such as the Summit Apex Plus could be said to have two users, the doctor\par and the patient, the manufacturer of the machine is considered by the law\par to have one user -- the doctor. It is incumbent upon the doctor to\par explain the risks associated with the medical procedure to the patient.\par
It is my suspicion that the word "learned" also carries with it the\par essence of integrity.\par
Perhaps you can help me. Did the operation performed by Dr. Gordon\par using the Summit Apex Plus cause my ocular surface disease to manifest\par ?? It appears to me that the operation has had this effect.\par
Although I have spent perhaps 3 hours in Dr. Gordon's company over two\par years, I can not recall any time when he has acknowledged that I have blepharitis. \par However, after five minutes with two different HMO ophthalmologists, I\par have been told the same thing ... "You have blepharitis." Is it possible\par that the Summit Apex Plus caused my blepharitis ?? Did it exist pre-operatively\par ... is it possible that Dr. Gordon neglected to diagnose and disclose it\par ??\par
Based on my contact lens intolerance prior to the LASIK procedure, and\par the quickness of the HMO doctors to diagnose this condition, I conclude\par that I had ocular surface disease before the procedure, but was asymptomatic,\par except when I tried to wear contact lens'. Then, I underwent the\par LASIK procedure, and the symptoms manifested assertively in my left eye.\par
I am afraid a similar scenario may have occurred relative to my esotropia. \par
My Mom, who took the enclosed photo-with-eyeglasses in 1997, recently took\par
one look at it and said, "yes, you're a little cross-eyed in this photo." \par
What do you think ?? Do you think the LASIK procedure caused\par
my esotropia to\par
manifest, or that it existed pre-operatively ?? I understand\par
that conventional eyeglass' contain a limited\par
prism correction. Is it possible that my esotropia pre-existed\par
the LASIK operation, that it was not diagnosed and disclosed, and that\par
the primary symptom of the esotropia -- double-vision -- manifested only\par
after the operation, when my eyes were functioning without the prosthetic\par
aid of eyeglasses ??\par
Of course, before the LASIK, my right eye was my dominant eye. \par
After the LASIK, my slightly-crossed\par
left eye has the better visual acuity. Perhaps this shift of\par
visual acuity away from the dominant eye is an important factor in my vision\par
complications.\par
In any case, I note two references to "strabismus" in the FDA literature. \par On page 178 of the Second Day of the Ophthalmic Devices Panel convened\par on October 21, 1997, there is a fascinating exchange between Drs. Stulting\par and Macsai ...\par
Dr. Stulting: Well, they don't have it. They have latent\par
strabismus. They have --\par
Dr. Macsai: But this is fine. They are at risk for developing\par
strabismus if you treat them.\par
The URL for this section of the Proceedings is ...\par
http://www.fda.gov/ohrms/dockets/ac/97/transcpt/3344t2.pdf\par
Note ... it is in Adobe Acrobat file format.\par
Well, if LASIK can cause strabismus, I think it's time to get the word\par out.\par
Contrastingly, in a paper entitled, "Discussion Points for Expansion\par
of the "Checklist of Information Usually Submitted in an Investigational\par
Device Exemption (IDE) Application for Refractive Surgery Lasers" Draft\par
Document", on page 7 there is an Examination Schedule and list of Exclusion\par
Criteria.\par
Down at the bottom of the table is a row entitled "Subjects at risk\par
for developing strabismus posttreatment." For persons with "Low to\par
Moderate" and "High" Myopia, with and without astigmatism -- I would characterize\par
myself as being moderately myopic with minimal astigmatism pre-op -- the\par
box is checked NA, for Not Applicable. The URL for this paper is\par
...\par
http://www.fda.gov/cdrh/ode/rslaschk.html\par
Based on my own experience, the Stulting/Macsai interchange, and the\par experience of "Phil", who has experienced bi-lateral strabismus following\par multiple laser ablations, I think that box on that page of the Checklist\par should have a "Check" for "Applicable", not NA.\par
In other words, the evidence suggests that ocular muscle dysfunction\par is an occasional side effect of laser corneal ablation, and the public\par -- the consumers -- deserve to know thiss.\par
I suggest that it is both wise and ethical for the manufacturers of\par ophthalmic laser workstations to put BIG warning labels on their workstations,\par describing all risks alliterated to in the medical literature, the FDA\par clinical trials, the Summit and VISX SEC filings, and the Surgical Eyes\par website. If a doctor as experienced in refractive surgery as Doctor\par Gordon can have patients with the results I am experiencing, then ... I\par don't know what to say.\par
Hitherto, the medical suggestions that I have received have been two-fold: \par to help me deal with the foreign-body sensation (pain) in my left eye following\par the LASIK surgery, and to help correct the esotropia in my left eye. \par For the former, it has been recommended that I consider wearing a transparent\par shield over my left eye, to increase the humidity. And/or buy a humidifier,\par and/or move to Florida.\par
For the latter, eyeglasses with a prism correction are apparently a\par logical avenue to explore. The one pair that I have had prepared\par thus far, specifically for near-sighted vision to get me back to being\par a 12-hour-a-day computer nerd, did not achieve the objective. It\par was more fatiguing than the eye-patch that I now use to achieve clear vision.\par
In fact, in 1990 I worked for 3 months as an engineering consultant\par for Phoenix Laser Systems, with a team of about 60 technical contributors\par charged with the task of developing an ophthalmological surgical workstation. \par My responsibilities included the finite element modelling and analysis\par of the optics for resonances, and the 3D modelling of a device used to\par measure corneal topography. I was laid off a month before what I\par guess to be their final "downsizing."\par
Before my LASIK surgery, I was a bonafide 12-hour-a-day computer nerd. \par Now, after 7 hours on the computer, my eyes and brain are fatigued. \par This is not satisfactory.\par
I am 41 years old.\par
I presently have a very strong need to understand what has happened\par to my vision. You are more than welcome to contact me at this email address -- rogerebratt@yahoo.com.\par
I have enclosed copies of my medical records, as recorded by Dr. Gordon,\par along with recent color topographical charts. If you can suggest\par a doctor who can help me understand what has happened to my vision, I welcome\par the suggestion. I do not relish the idea of wearing a transparent\par goggle with prism correction over my left eye for the rest of my life.\par
Anything you can do to help me develop a clear picture of what has happened\par to my vision is most appreciated.\par
Yours truly,\par
Most Sincerely,\par
~ Roger ~\par
Roger E. Bratt\par
\par
