Thursday, January 15, 2015

Dean Kantis
Sent: Thursday, January 15, 2015 8:25 AM
Cc:;;;; Dean Kantis
Subject: Criminal Investigation Involving FDA Employees: Malvina Eydelman Re: LASIK FDA APPROVAL/FALSIFIED SAFETY STUDIES since 1995.

January 15th, 2015

“The Public Is Being Completely LIED To, Deceived, And Purposely Injured By LASIK Centers”

Re: LASIK elective surgery / FDA / CDRH Executives are not following FDA protocol…

“Dear HHHS Inspector General,”

First, thank you for putting 15 minutes aside today, to take the time to investigate my accusations.  In fact, to save you time, here’s a “mini-film” that we created to succinctly explain this problem: .

The FDA and their office of Internal Affairs is a “broken entity.”  For whatever reason, they refuse to look into a matter where one of their “Directors” spent $1 million on a 6.5 year Quality of Life LASIK Safety Study (attached) that actually proved that LASIK (elective surgery, not necessary in the first place), has inflicted permanent damages into 30% or more eyes at months 3-6, Post LASIK and yet the Director of the FDA, Malvina Eydelman, spun the study as if it was safer than ever.  So my question to you is, “Would you fly in an airplane that crashed 1 in 3 flights because that’s about the safety/efficacy of LASIK and the FDA won’t issue the proper PHA “Public Health Advisory” to warn the consumers who think because it’s FDA APPROVED, that means it’s 99.99% safe/effective when in reality, it’s not.  Even the ex-chief of medical devices who led the team to the FDA APPROVAL of LASIK, Dr. Morris Waxler, petitioned the FDA back in Jan. 6th, 2011 and has since been ignored and “black flagged” by the FDA and other corresponding governmental departments.

Where Is The Proof:

Go into any grocery store or pharmacy.  Notice all of the POST LASIK DRYNESS DROPS?  Even your own Dr. Frederick Ferris put this into his presentation a few months ago at the AAO/Chicago conference in Oct. 2014.  The consumer is not being protected, and if you look at everything the FDA/CDRH has done since the inception of LASIK, they only protect the industry and are “tapped” into their positions and put their by industry to hurt competition and to maximize profits whatever the cost to the consumer who thinks their BILLIONS annually are spent to make sure that this kind of malfeasance and egregious behavior is non-existent.

Probable Cause:

If you see my email below, one of many, you will see that we have issued no fewer than 4 complaint cases accusing the FDA of “misappropriation of funding” aka “malfeasance,” and that the Director of Ophthalmology, Malvina Eydelman, blew through 6.5 years to push this problem/epidemic out when it shouldn’t have taken more than a year, and now after the study concluded (started back in 2009), and after $1,000,000.00 USD has been spent, the study (attached: called “Malvina Eydelman FDA-NEI Prowl Results”) showed according to her depiction, “that LASIK is the most studied procedure and is safer now than ever before…”  In fact, she was so excited to start off the AAO that she was the first presenter to share the supposed “good news” and set the pace.

 We are accusing of both Jeffrey Shuren and Malvina Eydelman of the following:

• a violation of any law, rule, or regulation,
• mismanagement,
• a gross waste of funds,
• an abuse of authority, or
• a substantial and specific danger to public health or safety

Who is Dr. Perry Rosenthal:

Even Dr. Perry Rosenthal, Assistant Ophthalmologist, Harvard University and founder of the Boston Foundation For Sight, is an outspoken critic of LASIK yet complains that his studies that “warn that LASIK is a bad idea and inflicts disease and inflammation” will not get picked up by any of the journals.  In other words, anyone or anything that doesn’t “BOAST” that LASIK is completely safe/effective 95% or more of the time, won’t get published and that person who did such will be “black listed” by the industry and by his/her peers.

Dr. Rosenthals Credentials: 

What is BioShape Known For Proving And Why Hasn’t Their Study Been Published By The Ophthalmic Journals:
BioShape is a company that has proven that every LASIK eye surgery, permanent flap/scar creation, has always has “KNOWN PERMANENT INJURIES” and yet a group of American Opthalmologists appointed by Alcon knew this when they hired Daniel Kluting and Stephan Schrunder (Attached:  Bioshape 2004, 2005, 2006 results of studies), yet they were fired since they proved that LASIK was a Titanic and was proven to create a “Permanent Golf Divot” into each of it’s victim’s cornea, creating a loss of 98% of the eye’s tensile strength, creating permanent Dry Eye or existing Dry Eye made much worse, and lastly creates “Uneven Tear Film Distribution,” to name but a few known permanent injuries of which, the industry is stating “these are just mere temporary symptoms and side effects and will go away in a few months or at the latest by Months 3-6…” Yet they don’t go away and the industry knows this, and has known this all along.  These are instead properly referred to as:  “PERMANENT INJURIES – ADVERSE EVENTS – SERIOUS ADVERSE EVENTS” and the industry won’t use these proper terms as then they would have to file the appropriate MDR Medwatch Injury Cases/Reports Here into the FDA’s Reporting system which no one at the FDA is policing or reading anyway: 

Report a LASIK Problem:

If the FDA checks, they would now find that there are over 4,000 Medwatch Cases for LASIK and PRK elective and irreversible procedures known, and growing yearly.  Mostly, created by patients and not by their physicians, so you can imagine how much larger this number and epidemic would grow to if physicians and trained staff were reporting every “retreatment/enhancement,” “dry eye prescriptions for RESTASIS,” and “other visual disturbances.”  Yet, they aren’t reporting them because they know that no one is policing them…especially the FDA or CDRH!
Please now see the bottom thread of this email to see how the FDA continues to ignore this.  When I called into the FDA’s Office of Internal Affairs, they “hung up on me.”
So my advocacy work is completely disrespected, all pro bono, since the FDA seems “broken and incoherent” when anything negative is mentioned or reported regarding LASIK/PRK elective surgery.

See for yourself below!

Thank you.


From: Dean Kantis
Sent: Tuesday, December 16, 2014 12:21 PM
To: Gonzalez, Alberto
Cc: Jim Dickinson; 'Morris Waxler'; Dean Kantis; Larry Pilot
Subject: Criminal Investigation Involving FDA Employees: Malvina Eydelman Re: LASIK FDA APPROVAL/FALSIFIED SAFETY STUDIES since 1995.

December 16, 2014

Hello Mr. Alberto Gonzalez:
(FDA Office of Internal Affairs)
I called today to check in and see if any progress has been made on my case report and unfortunately for me, was unable to reach you, but instead reached a Mr. McCormick who was extremely naiveté and rude by not wanting to give me the time of day on anything and
hung up on me.  He knew who I was and called me Mr Kantis.  I then called back and a Mr. Rubin picked up.  He tried to answer my simple question asked which was “who is in charge at the FDA of deciding whether or not this case/complaint is going to be investigated” and tried to pawn me off on an ex FDA compliance department employee who I know of doing the same thing, called Mr. David Buckles who is no longer at the FDA/CDRH and was working under Steven Silverman who heads Compliance.

Anyway, to my dismay, this department has been completely rude, totally unprofessional, and “hanging up” like a bunch of children playing games and pranks, isn’t the way to handle a consumer who is helping your department for FREE to police/register possible medical criminals.
The fact that I’m being blown off again, by a department who is being paid by our hard earned tax paying dollar adds further insult to injury.  Lastly, may I ask you the same question “Who at the FDA/CDRH is in charge of deciding whether or not this case is going to be investigated?”

Thank you for the courtesy of your reply.


My best to you,
Dean A. Kantis

From: Gonzalez, Alberto []
Sent: Friday, December 5, 2014 1:02 PM
To: Dean Kantis
Subject: RE: Criminal Investigation Involving FDA Employees: Malvina Eydelman Re: LASIK FDA APPROVAL/FALSIFIED SAFETY STUDIES since 1995.


Mr. Kantis,

I received your email which will be forwarded to the attention of my supervisor.

Thank you.


SA Alberto L. Gonzalez

FDA Office of Internal Affairs

(240) 276-9393


From: Dean Kantis
Sent: Friday, December 05, 2014 12:52 PM
To:; Gonzalez, Alberto; West, Robert
Cc: 'Morris Waxler'; Jim Dickinson; Dean Kantis; 
Roger Davis; Michael Patterson; Larry Pilot
Subject: Criminal Investigation Involving FDA Employees: Malvina Eydelman Re: LASIK FDA APPROVAL/FALSIFIED SAFETY STUDIES since 1995.

December 5, 2014

Dear OIG, OCI, and HHS Offices of Criminal Investigation,

My complaint for a Criminal Investigation from an external FDA Office: 
There is a conflict of interest with the Director of Ophthalmology, Malvina Eydelman, and possibly the Director of Devices, Jeffrey Shuren, in showing “biases’” to the medical industry, Protecting the profits, safety studies, financial interests, and reputations of physicians in and around the Safety Studies involved with PRK/LASIK/Refractive Surgery, and this has been going on since the 1990s (see bottom of this email Part 1-7).  How can the OIG, OCI, and HHS work in harmony to conduct an investigation into the matters of LASIK NEVER BEING WORTHY of FDA Approval, the original studies / ongoing safety studies prove, that the lasers used in LASIK are about as safe as going up in an airplane and crashing 1 in 5 flights.  This is why we need your attention into this matter.  The public thinks that because LASIK is FDA Approved, that means that it’s 99.99999% safe or that means to them that if they fly in an airplane, they have a 99.99999999% chance of safely flying…This is certainly NOT the case and the FDA needs to do the right thing and warn the consumer since the industry chooses to deceive the consumer.  If you take the time to thoroughly investigate this, you will find the same thing, that LASIK should have never have been approved and represents a danger to the public!

First, I’m contacting the OIG due to YOUR WEBSITE stating this:
Disclosure by current and former Federal employees and applicants of the following types of wrongdoing are covered by the Whistleblower Protection Act of 1989:
• a violation of any law, rule, or regulation,
• mismanagement,
• a gross waste of funds,
• an abuse of authority, or
• a substantial and specific danger to public health or safety

A little background about what has transpired since I have had LASIK on Aug. 24th, 1999:

As a consumer, I feel very wronged, that the FDA and Medical Agencies would allow a permanently injured/disabled person like myself to get sued for $2million dollars by my LASIK doctor
Nick Caro in Chicago/IL, in an effort to show me that he can try to quiet me from speaking out about his 60+ LASIK LAWSUITS.  Maybe he knows something that I don’t know about no one
investigating or policing his center?  Or…that all of my attempts to have Dep’t of Regulations investigate him and follow doctors that lied to me, to protect him, would get DENIED.  Perhaps…
But hopefully with this email, you will prove me wrong.

Please understand, I have turned in no fewer than 15 complaints over the past 6 years into the investigation of LASIK officials involved in the FDA Approval of LASIK, The Safety Studies involved in the original FDA Approval of LASIK, and the continued Safety Studies Involved in LASIK.  In addition, by hearing from no fewer than several thousand injured LASIK patients that have all said the same thing, we have concluded that there is a Medical Coverup/Conspiracy involved at the highest Director positions inside FDA/CDRH and those physicians and OEM medical Executives that continue to make millions/billions annually off of the sale of:  1.  LASERS used for LASIK and PRK Refractive Surgeries.  2.  Future Surgeries/Enhancements/Retreatments.  3.  The Micro-Keratome
Blades and FemtoSecond Lasers used in Refractive Surgeries.  4.  Post LASIK Restasis Prescription and Dry Eye Drops for LASIK Dryness.  5.  Early need for accelerated aging of the eye and Cataract Surgeries.  5.  Misc:  Office Visits, Ectasia/Keratoconus induced surgeries, Corneal Transplants, Vitrectomy surgeries, etc.


PETITIONS to FDA continue to be IGNORED:  Dr. Morris Waxler oversaw the group that approved LASIK back in 1996/1997.  Flash forward to Jan. 6th, 2011:  Dr. Waxler petitions the FDA to immediately “PULL THE LASIK FDA APPROVAL” and issue a “CRIMINAL INVESTIGATION.”  See attached, official correspondence of Petition/Petition Denial to Morris by FDA.

Waxler on TV begging the consumers to listen and to NOT DO LASIK or trust the FDA:

Dr. Oz LASIK Warning:  “Stated 1 in 5 eyes are permanently being ruined:”

We spoke out against LASIK at the April 2008 hearing, but the entire Panel of Ophthalmologists wearing glasses hasn’t replied to us since: .

Mini Film we made that explains this in a few minutes: .

Malvina Eydelman/Jeff Shuren:  Directors of Ophthalmology and Devices:
-Why aren’t physicians such as Nick Caro/Chicago, IL who ruined my eyesight and has accumulated 60+ LASIK LAWSUITS

Being disciplined as FDA/CDRH is supposed to be doing (3 years imprisonment and $1million in fines is what the FDA’s website shows):

-$1m was just spent on another “4 year Supposed Safety Study” to see whether or not LASIK meets FDA approval guidance, which it still does not, and the study proved that they don’t know…(See attached presentation by Malvina Eydelman:  FDA – NEI PROWL RESULTS).

-Malvina Eydelman's 6 year So Called QoL LASIK Safety Study proves LASIK is unsafe and immediately she has a responsibility to issue the proper consumer PHA "Public Health Advisory" to prevent any families from being permanently injured:

-See presentation by Fred “Rick” Ferris, Director of the NEI who actually is trying to get the medical community to look at the Dry Eye Disease problem that LASIK is causing:
 -Dr. Steven Schallhorn has made MILLIONS off of his Femtosecond Laser and LASIK, and yet is in charge of the Safety Studies ongoing? .  Malvina is very close to Schallhorn and yet
this is allowed?

He and others like him, are teaching physicians to tell patients they should love their LASIK vision even if it’s distorted and blurred like this photo above and calling them a “success.”   Does this look like a "SUCCESS" to you?
-Any Safety Study that goes against the industry and the doctor who reports the study, is black listed, and it doesn’t get published in industry news: .

-Epidemic?  Signs everywhere, just look: .

Even the Ophthalmic Industry is saying that there are "ethical" challenges, just look at their cover:

Go back to how LASIK got approved and you will find this investigation
(My apologies for the poor video quality, turn up and listen to what happened):

Part One:    (10 minutes)

Part Two:    (10 minutes)

Part Three:     (10 minutes)

Part Four:    (10 minutes)

Part Five:   (5 minutes)

Part Six:  (10 minutes)

Part Seven:  (10 minutes)

Now...that we have given you background on the Summit Technologies founder/CEO, David Muller, put the pieces of the puzzle together and discover how LASIK ruined so many eyes and now those eyes are inflicted with "SICKNESS and DISEASE" and years later are coming in complaining of exponential and never ending problems.  So lets see what David Muller is up to now, years later, and why...Avedro's CCL "Cross Collagen Linking" Process To Help LASIK Flaps STICK and NOT POP:  .

My speech at the 2008 Emergency LASIK Panel discussion begging the FDA and industry to help us and listen to us, nothing from them since:

In closing, my question is quite simple and please don’t take this as being a patrionizing question, but it is this:

“If you didn’t know all of this prior to now…meaning…you didn’t see or hear this on the news or have been warned about this by a doctor…by the FDA directly…then how would you or any other consumer know this danger prior to getting LASIK?”  If the answer is, “they wouldn’t know this or be warned,” then how is a consumer to be warned of this danger if the FDA continues to protect industry and only spin safety studies to “appear” to be safe when they are “not safe?”  And why aren’t physicians being held accountable for violating safety laws and why aren’t the Directors at the FDA implementing FDA protocol of (3) years imprisonment and $1million in fines as stated above on the FDA’s website/link page?  How is a permanently injured/disabled consumer like me to see this as “being fair” to the consumer when this is allowed to perpetuate and there is no response by any departments to injured consumers like myself who spent hours today typing this and doing this for free/pro bono in an effort to warn the public and protect the public?

Please investigate this…Please hold those accountable… Please follow your job descriptions, mission statements, Hippocratic oath sworn to "first" protect the consumer and in criminally investigating possible fraud, corruption, and crimes by FDA officials.  Please reply that you will look into this…

Thank you for your consideration…

My best to you,

Dean A. Kantis

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