I think many of the problems from reusing microkeratome blades go unreported.  LASIK is reported to cause many problems so there is no debate that they occur.  Some Doctors state they have Never had many of these flap problems in ANY patient.  Are these the Doctors who use new microkeratome blades?  The FDA and the CDC will Never find out because they claim to have no jurisdiction.  So what if a few million people have these problems unnecessarily? 

The question is how often do these problems occur and how much more likely are they to occur with a reused microkeratome blade (with or without sterilization) versus a new microkeratome blade?  No one knows the answer to these questions.  There is no way to ethically do a controlled clinical trial because the blades should Never be reused (this is my opinion- there may actually be some published clinical trials with reused blades).

IF Doctors who do "second opinions" after LASIK (this is a big business due to all the people with problems) are used to seeing good results from LASIK, then why aren't the Damages from reusing microkeratome blades obvious to them?  As odd as it sounds, many patients have told me their Doctors acted as if they did Not believe what they were telling them about their eyes and vision.  My own statements about my vision and eye pain, etc. do Not appear in many of my medical records, and some Doctors have one diagnosis but Not others (in some cases I initially found out Only by getting copies of my medical records because some of the Doctors did Not tell me they had put these diagnoses in my records).  One Doctor who was on the FDA's Ophthalmic devices panel said the objective evidence (without reviewing my artemis or confocal exams) was Not consistent with what I said about my vision.  I was shocked when he said "I know many patients who would be happy with your vision".  I'm sure that blind people would be happy with my vision, but how does that help with my terrible vision and eye problems that bother me all the time?

Because the cornea is clear, transparent tissue some Damage to the cornea may Not be readily apparent even after a thorough exam by an eye Doctor.  More sensitive equipment and diagnostic tests are Not available in most eye Doctors' offices and are only available to a select few Doctors.  Even if self-paying without insurance, these tests can only be ordered after with a medical diagnosis (which some Doctors are reluctant to provide without prior objective evidence).  Doctors are required to file Medical Device Reports with the FDA and are Not expected to record everything.  Furthermore, many infectious diseases have no symptoms for years (including Aids/HIV and mad cow disease, CJD can only be detected after death). 

Here is a list of a few, not all, of the eye problems I have had that were Not detected by one Doctor or diagnostic device or the other. The details regarding why these were Not always detected by the Doctors are discussed below.  All of these problems could be caused by Not following the Microkeratome Operators manual insructions and/or reusing the microkeratome blades.

1.  A 1.3 x 3mm scar and "clumps" of something under the flap (one measuring ~40um, 5 x 8) as measured by a confocal microscope exam.

2.  Thin, irregular, uneven flaps and epithelium as observed only by an Artemis Ultrasound exam (see below).  "The Bowman’s membrane interface is irregular in character, with occasional breaks, indicative of microfolds or striae." (Two Doctors who did FDA clinical trials said there was "NO striae" just before I had the artemis exam).  Multiple Microkeratome cuts as observed only by the Artemis and removal of the epithelial layer during a follow-up surgery. 

"When I mechanically remove the epithelium, there were 2 semicircular demarcation lines, one indicating the outer limit of a LASIK flap, and the other about 2 mm inside the outer line and extending for about 3 mm superiority.  This most likely represents a second, incomplete LASIK flap."

3.  Mebomian Gland Dysfunction and Keratitis- Diffuse Lamelar Keratitis (DLK), Punctate Epithelial Keratitis (PEK) and superficial punctate keratitis (SPK) resulting from LASIK-induced dry eye syndrome.

4.  Severe loss of vision quality including 4 diopters of spherical aberrations (Not sure which test showed this because the Doctor cancelled my appointments, but could be the Interwave which is Only used by a few Doctors in the entire country- who work in just one location). 

Read more: Flap Damage