The FDA hasn't even responded to my request for humanitarian aid or compassionate use of a medical device.  They don't do anything about Doctors Not providing the Patient Handbooks, violating the labeling (including false advertisements), or Not informing patients they are getting a "off-label" treatment, but when I asked the FDA to simply put in writing that the manufacturer and my Doctor can do a treatment zone .5mm wider than the current 6.5mm maximum approved by the FDA (to come closer to matching my actual pupil size), the FDA will Not put it in writing.  Is that humanitarian or compassionate?  I think not. 

"a Humanitarian Device Exemption (HDE),H000002, was approved for the Custom Contoured Ablation Pattern method for the treatment of certain patients with symptomatic decentered ablations from previous laser surgery, as viewed on the Zeiss Humphrey topography unit."

http://www.fda.gov/ohrms/dockets/ac/02/minutes/3883m1.htm 

The damage to my eyes is uncorrectable with the current technology available in the United States and my prognosis is Not good.  I have yet to find anyone who would Not be upset to find out that his/her Doctor reused a needle on multiple patients before his/her flu shot.  I have Not been able to get justice or liberty from my ruined vision and eyes.  There was a microkeratome failure in my eye, but the Doctor wrote "went well" in my medical records.  Based on the evidence I now have finally, I have an expert witness specifying seven (7) breaches of the standard of care (e.g., medical malpractice) Not including the reuse of the Microkeratome blades (the Doctor didn't write that in the records either).  I have a LOT of circumstantial evidence- check out his own website where he says to ask your Doctor if he changes the blade between patients. 

 

"Does the center sterilize all the instruments for each eye and use a separate blade for each patient? "

http://www.charlestoncornea.com/index.cfm/laservision/lvcchecklist

 

 

Why would he say to ask if he didn't know someone who was reusing the blade on multiple patients? 

 

This Doctor didn't even do what he recommends before surgery on me, but none of the expert witnesses I consulted said these are required in the standard of care.  The government won't help you.  If you have a bad result, you're out of luck. 

Does the center measure the size of the patient's pupils in order to ensure the appropriate treatment zone is used to avoid post-operative side effects?
Yes
No

Does the practice test for dry eye before the procedure?

Yes
No

Does the center take the time to explain complex issues such as blended vision and presbyopia and how they will affect your vision after age 40?

 

 

My answer is a definite NO, NO, NO to these 3 questions.  My life has been ruined forever by LASIK surgery as it was done to me.  Other Doctors say that Not telling me about these obvious issues is within the standard of care for the practice of medicine so patients have no local or State recourse for these obvious violations of the ethical guidelines about informed consent.  If Doctors can ommit obvious problems to the FDA and to patients, and patients have no recourse, then what checks and balances are there to encourage users of the FDA regulated medical devices to use them safely as they are intended to be used? 

 

 

I have been to numerous Doctors and I have tried everything reasonably possible (there are some very risky things I have not tried yet like cornea transplants and autologous serum), but I still consider my life to be constant torture now.  LASIK is approved by the FDA as “safe” with low complication rates reported with proper use during clinical trials, but I have had numerous very serious complications (reuse of the microkeratome increases the risks of these) including, but not limited to,

1)      Diffuse Lamelar Keratitis, DLK
2)      Bumps of particles under the flap (metal fragments or clumps of cells that could have been transferred from other patients eyes- is there DNA from other patients under my flaps?)
3)      Epithelial defect
4)      Flap Melt
5)      Flap Striae
6)      Both eyes have very irregular, thin flaps that vary in thickness from ~30um to ~110um
7)      Corneal abrasions
8)      corneal Haze
9)      irregular astigmatism
10)  more than double an increase of higher order aberrations (pre vs. post LASIK). 
11)  Very Severe degree of spherical aberrations (one of the higher order aberrations)
12)  breaks in bowmans membrane (not visible under the slit lamp- only shown in an artemis ultrasound exam)
13)  scarring
14)  multiple microkeratome cuts
15)  dry eyes and related diseases (e.g., blepharitis; mebomian gland dysfunction- MGD; epithelial basement membrane dysfunction- EBMD also keratitis, SPK,PEK, epithelial defect, abrasion, etc.; reduction of vision quality and contrast sensitivity; reduction in tear film quantity and qualiy- reduced schirmers scores, many patients with 0).
16)  permanent reduction in vision quality and contrast sensitivity (dry eye, aberrations, glare, halos, starbursting, glare, haze, visual acuity loss, degree of visual impairment in low light/night time, ordinary tasks like driving more difficult, etc.). 
17)  permanent reduction in quality of life
18)  Multiple surgeries

Note that these complications provide circumstantial evidence that the blades may have been used before being used on my eyes because complications (especially flap complications and higher order aberrations) are More likely to occur if a microkeratome (e.g., the blade or cannula) is incorrectly reused (on multiple eyes or multiple patients).  I was told that I “got what I paid for”.  I paid $995 per eye and they have advertised both before and after my LASIK surgery that they do exactly the same treatments for $299 per eye.  I have also met a person who also had an incomplete flap from Dr. O’Day (I can provide her name and phone #).  With the low incidence rate of this complication with a new microkeratome blade, I estimate the odds of two people who had this same complication with the same Doctor are 1 in 10,000,000. 

I have talked with other patients who are extremely angry and upset about their vision after LASIK with Dr. O’Day and after LASIK at LVI with other Doctors.

 

Would you let someone do this to your eye with a blade that was reused on other patients?   

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