The LASIK industry & the FDA have conspired since LASIK's inception to purposely withhold information vital to the public in making a truly informed LASIK decision. With, The hope is to show you what the industry and FDA would not and did not even think of doing until LASIK casualties started speaking out, and yet, they still did NOTHING.
FDA Related PDF Print E-mail
Saturday, 03 December 2005 19:00

FDA's LASIK Website

Although I feel the FDA has protected many doctors, companies, and themselves, they still have somewhat of an an informative LASIK Website (Although I believe severely biased given the lack of authority to protect the public).

Link To Site

Is ANY Laser really safe?

Not just investigational lasers, but those WITH approval from the FDA...

Alcon lasers

There were a whole bunch of new MDRs filed in the Maude database during December about breakdowns of Ladarvisions. They make interesting reading. Go to:

(Type in "ladarvision" and search)

"CUSTOMCORNEA" into the search and got this one:  "Alcon customcornea & ladarvision 4000 wavefront lasik machines were used to preform enhancement surgery on left eye after original lasik in 2003. Enhancement surgery made eyesight worse; nearsighted again with multiple vision effect when looking at point of light. 2nd, 3rd, 4th opinions from other drs confirm irregularities in cornea from enhancement surgery and all of them say that the alcon customcornea wavefront measurement device and the ladarvision laser should not be used for enhancements because the software is not sophisticated enough and is too unstable."  Not only their machines, but their stock as well:




And promotion of an Investigational Device.

Read More

FDA Warning for Risk of Dry Eye Complications




Some patients may develop severe dry eye syndrome. As a result of surgery, your eye may not be able to produce enough tears to keep the eye moist and comfortable. Dry eye not only causes discomfort, but can reduce visual quality due to intermittent blurring and other visual symptoms. This condition may be permanent. Intensive drop therapy and use of plugs or other procedures may be required.


It does happen!  And the people I've spoken to with these complications let you know the risks are severely down-played by the FDA.  These symptoms are VERY painful!


And doctors want patients to think that DLK and infectious keratitis just happen for no reason...

Ophthalmic Devices Panel Meetings


This FDA panel meeting has a rather disgusting section where concealing the fact that refractive surgery induces dry eye from the consumer is discussed. The panel decided not to require that ALCON disclose that dry eye after refractive surgery is an industry-wide problem... because they hadn't required other LASER companies to include dry eye warnings in their labeling previously. So they claimed it wouldn't be FAIR to ALCON to have to admit in their labelling that refractive surgery induces dry eye. How about being fair to patients so that they can be properly informed about LASIK dry eye BEFORE they decide to have surgery?

Loss of corneal nerve density averaging more than 40% at the 3 year point after LASIK? No thank you!

This link will allow you to find transcripts of all Ophthalmic Devices Panel meetings. Click on the year, then scroll down and look for Ophthalmic Devices.

Before you start clicking and reading, it helps to know which meetings were called to review lasers for refractive surgery.

Here's a link to the summaries of these meetings from 1997 through 2000:

More recent meeting summaries can be found at this link:

Click on "Ophthalmic Devices Panel", "Past Meetings".

Past FDA Actions showed industry bias from the very beginning:

When Charles Casebeer began the PMA presentation to the FDA panel, he stated he had " financial interest in any of the products involved..."

But!  Did Casebeer have a financial interest in any related product?  Namely, the LaserSight microkeratome?

Do you find it odd that in the fall of 1998, Dr. Casebeer speaks of his part in developing a keratome that was marketed by LaserSight in the article on the Refractive Eye Care website?

"I put almost two years into helping to develop the Ruiz disposable keratome (now being marketed by LaserSight as the Automated Disposable Keratome [ADK])"

What was Dr. Casebeer's connection to LaserSight when he presented the PMA to the FDA panel on July 22, 1999?  Doesn't it seem likely that Dr. Casebeer had a financial interest in getting the VISX approval for LASIK in that it would create a huge need in the industry for microkeratomes?  Read from the LaserSight Technologies website under press releases.  This press release is dated 7/27/99 -- just 5 days after Casebeer made the VISX LASIK presentation to the FDA Ophthalmic Devices Panel.


Winter Park, FL (07/27/99)

Winter Park, FL, (July 27, 1999) -- LASERSIGHT INCORPORATED (Nasaq:LASE) announced today that it began shipment of its ULTRA EDGE™ Keratome Blades in the United States, Canada and other international markets. The shipment marks LASERSIGHT's entry into the market for per- procedure laser vision correction products on a value-added basis to physicians and patients. The keratome is an instrument used to cut a thin corneal flap just prior to the LASIK procedure. These blades are the product of a joint venture between LASERSIGHT and Becton Dickinson, Inc. (NYSE: BDX). As previously announced, LASERSIGHT and Becton Dickinson Ophthalmic Systems entered into an exclusive agreement to develop, manufacture and distribute keratome blades. The market for laser vision correction is rapidly expanding, with the number of laser vision correction procedures in the United States expected to exceed 800,000 in 1999 and 1.2 million in 2000. Becton Dickinson Ophthalmic Systems is the worldwide leader in the manufacture and sales of surgical blades and ophthalmic cannula under the Beaver and Visitec brands. The keratome blades are automatically processed and manufactured utilizing surgical grade stainless steel. Becton Dickinson's long history of manufacturing expertise should allow the venture to effectively respond to market demand for the product. Production is targeted to be in the range of 15,000 blades per month starting in August 1999. The Company will continue to closely monitor market demand and adjust production accordingly. The ULTRA EDGE™ Keratome Blades are manufactured utilizing a proprietary process and a material selected to yield a blade with superior cutting efficiency. Sharpness and cutting efficiency have been validated at the manufacturing source. Stephen A. Updegraff, M.D., a refractive surgeon practicing in St. Petersburg, FL, was one of a group of refractive surgeons who tested the keratome blades. Dr. Updegraff commented, "The blades represent a new standard of quality, and I am very impressed with the fact that they are manufactured from surgical grade stainless steel." Michael R. Farris, chief executive officer of LASERSIGHT, commented, "The launch of the keratome blades is a key element of our business plan as it is consistent with our stated strategy of bringing to market new products that complement our existing laser technology. In addition, the product enables us to tap into a recurring revenue stream that will be generated from replacement sales of a single use product into an expanding and growing market." Mr. Farris continued, "We are encouraged by the enthusiastic responses expressed by the surgeons who have used the product and believe our focus on quality and reliability will enable us to continue to gain market recognition. Going forward, we are uniquely positioned to meet the growing demand of this rapidly expanding market." LASERSIGHT INCORPORATED provides quality technology solutions for laser refractive surgery and other innovative applications, mainly in the vision correction industry. The Company sells its products in more than 30 countries. In the United States, LASERSIGHT 's refractive scanning laser system has a pending pre-market approval application with the U.S. Food and Drug Administration and is not yet commercially available in this market. This press release contains forward-looking statements regarding future events and future performance of the Company, including statements with respect to anticipated sales revenue, which involves risks and uncertainties that could materially affect actual results. Investors should refer to documents that the Company files from time-to-time with the Securities and Exchange Commission for a description of certain factors that could cause the actual results to vary from current expectations and the forward looking statements contained in this press release. Such filings include, without limitation, the company's Form 10-K, Form 10-Q and Form 8-K reports.    

From the FDA website:

Shorts Have Dim View of Sunrise Technologies' Success

"It's unknown how the panel will react to the fact that nine of the 11 chief clinical investigators listed on its own Web site have purchased sizable stakes in Sunrise, which was brought to light by TSC.

I'm Not Just an Investigator, I'm Also an Investor:

Nine of 11 main investigators on Sunrise's farsightedness laser have investments in the company.

Investigators Common shares granted*
David C. Brown 2,481,847
Donald R. Sanders 2,283,519
Alan B. Aker 1,948,109
Manus C. Kraff 1,003,931
Robert Gale Martin 677,840
Paul H. Ernest 77,353
Douglas G. Koch 13,500
Sandra C. Belmont 7,500
Peter J. McDonnell 5,000
*Beneficially owned. Source: Sunrise, SEC document of September 1998.

Coghlan sees no problem. "Does anyone really think that any of our clinical investigators, who are among the most respected names in ophthalmology, would do anything to hurt their reputations?" he asks.

Well, the FDA, for one, thinks it possible. In an overhaul of its policy on financial disclosure by clinical investigators, the agency wrote in March that it "has become increasingly aware of the existence of potentially problematic compensation arrangements between sponsors of FDA-regulated products and clinical investigators. ... These arrangements clearly have the potential to bias the results of clinical studies."


New Disclosure Rules for Medical Investigators Won't Apply to PR

Financial conflicts of interest involving clinical investigators of medical products are so common that starting in February the Food and Drug Administration will require all medical companies to disclose investments by investigators that are worth more than $50,000.

What won't be required, however, is disclosure of the investments held by supposed experts quoted in company press releases.

Take the case of Sunrise Technologies (SNRS:Nasdaq - news), the maker of an eye laser to treat farsightedness. The company points out in a recent registration statement that more than half of its clinical investigators are also investors in the company. (That's more than the norm, according to several industry observers, but at least it's disclosed.)

However, unless you read the company's Securities and Exchange Commission filings, you'd never know that Dr. Donald Sanders, who runs the Center for Clinical Research in Elmhurst, Ill., owns more than 5% of the firm. Sanders was quoted liberally in Sunrise's recent press release announcing that it had filed an application for FDA approval of its laser. Quoted in the same release: Dr. Douglas Koch of Baylor College of Medicine, a clinical investigator who, according to the registration statement, is also a Sunrise investor.

Shift over to Staar Surgical (STAA:Nasdaq - news), which makes implantable contact lenses, and there's Dr. Sanders being quoted again. (No mention that he's a director of the company as well as an investor.)

And it's all legit. All the FDA requires is that the comments be factual.

Neither officials from Staar nor Sunrise could be reached, but Sanders, whose firm consults on regulatory projects, sees nothing wrong with the lack of disclosure. Why? "It's not standard practice, that's why."


'Bermuda cards' allow off-label use of Visx laser


by Keith J. Croes
Executive Editor

An off-shore modification of Visx keycards allows U.S. surgeons to employ excimer laser treatments widely used elsewhere around the world.

A number of refractive surgeons in the United States are using Visx keycards that have been reprogrammed in Bermuda to override a software change ordered by the Food and Drug Administration a year ago, according to sources in private practice and industry.

At a rate of $40 per card, the Hamilton, Bermuda-based company, Technological Health Care Products (THCP) Ltd., "enhances" prepurchased Visx keycards meant for U.S.-sited lasers, a THCP official said. The card's original "international" program, used extensively outside the United States, is thus restored and available for use on the U.S. machine.

Legal issues

An FDA official charges that the cards are "illegal," which is probably technically correct, according to Wayne Matelski, an attorney who specializes in FDA regulations. "A component of a regulated device is a device itself, and the card is unapproved," he said. The FDA would argue that [the cards] are illegal and would probably seize them if given the chance."

The approved cards, which cost $260 each when purchased from Visx Inc., of Santa Clara, Calif., are hand-carried to Bermuda, or even sent by express mail, by laser center or practice representatives, not necessarily the surgeons themselves. Surgeons who use the reprogrammed cards point out their practice-of-medicine privilege to use an approved device for off-label applications.

"There is definitely a practice-of-medicine issue here," Matelski said. "It would be up to the court to decide. A pro-government court might be expected to favor the FDA over the surgeon. However, a well-respected surgeon in a regional court might prevail."

The reprogrammed cards allow the treatment of higher degrees of myopia and astigmatism than permitted by the approved labeling of the Visx laser. THCP believes that the company's service violates no U.S. or Bermuda laws. "We do not market directly in the U.S., and word-of-mouth is the only way we market. U.S. doctors personally contact our office here for keycards," said a THCP official, who declined to reveal his name. The FDA has not contacted the company, he said.

Numbers unavailable

The THCP official declined to reveal the number of cards the company has reprogrammed and the number of customers served. "The volumes have not been as large as we originally expected," he said.

A U.S. laser center executive, whose operation includes three Visx lasers, acknowledged sending one shipment of about 800 cards to THCP for reprogramming. "We think this is the high road compared to custom lasers and gray-market lasers. These are approved lasers with proven software," said the executive, who requested anonymity.

In a number of public statements, Morris D. Waxler, PhD, acting branch chief for the Diagnostic and Surgical Devices Branch of the FDA's Center for Devices and Radiological Health, has called the cards "illegal." Waxler pointed out that the agency recently outlined a regulatory pathway for surgeons who wish to apply for an investigational device exemption (IDE) for treating these patients.

"We are very sympathetic to the forces at work here, which is why we've developed a process so that surgeons who want to do these procedures can get an IDE or get into an established study," Waxler said. "The surgeons who are using the cards are not contributing to the data collection and interpretation going on in order for us to understand what we're doing to these patients."

CRS-USA reaction

CRS-USA Inc. is pursuing one such IDE with a study coordinated by Guy Kezirian, MD, of SurgiVision Consultants, Inc., Scottsdale, Ariz. "The Bermuda cards raise concerns for patients and surgeons alike," Kezirian said.

"Undergoing surgery with unvalidated technology that is obtained from an off-shore source leaves them with little recourse should a problem occur. The problem for surgeons is that they are left holding the entire bag for liability. Will their malpractice insurance cover them for activities the FDA says are illegal?"

With the recent approval of the Visx laser for low to moderate astigmatism, the demand for Bermuda cards will likely shrink, at least temporarily, industry sources predict. The pressure on the FDA to approve treatments for high myopia, however, is likely to grow.

Although Visx has heard reports of reprogrammed keycards, the company is not involved with the activity in any way, according to a Visx spokesperson. The THCP official also noted that THCP has no association with Visx.

FDA - Your Opinion?


"I hate the damn FDA. Its one thing for the laser makers to lie but it's another thing to know that your life ended because the damn FDA was too ignorant, too careless, or too corrupt to want to do it's job to stop them."


"the FDA says they dont regulate the practice of medicine. but lying to the FDA in order to perpetrate fraud on the public is not medicine. therefore, it is regulated by the FDA."

"the FDA says they dont regulate the practice of medicine. but lying to the FDA in order to perpetrate fraud on the public is not medicine. therefore, it is regulated by the FDA."

"so the FDA can do something if its wants to. the question is whether the FDA itself is so corrupted by special interests that it doesnt want to. my guess is that it is. how else would research that was obviously deceptive make it through the opthalmic devices panel and be approved? if the fda took some kind of action, it might well have to admit to millions of consumers that they are facing long term damage to their vision. it could cause a lot of embarassment. so the fda is silent, just like almost everyone is silent."

Available to the Public

Available to the Public

Over 1,000 pages of additional documents (now available on CD) are available to the public on request to this website. Please email me for more details.


SOURCE (EyeWorld - August, 2006)

Inside the FDA: Reporting of medical device-related adverse events

by Malvina Eydelman, M.D. and also, an ophthalmologist. She is director of the Division of Ophthalmic and ENT Devices (DOED) in the Food and Drug Administration (FDA)/Center for Devices and Radiological Health (CDRH)/Office of Device Evaluation (ODE). 

I have written several columns about how the Food and Drug Administration (FDA) regulates the routing of ophthalmic devices to market. FDA’s involvement in the medical devices, however, is not limited to the pre-market arena.

FDA monitors post-market reports of device-related adverse events/product problems (AEs). This is done to detect "signals" of potential public health safety issues, and it is an important aspect of FDA’s role.

Primary responsibility for this function is carried out by the Center’s Office of Surveillance and Biometrics. The interdisciplinary staff of clinicians and engineers that reviews these reports is headed by Tom Gross M.D., M.P.H. He provided his expertise in writing this column.

FDA’s ability to take appropriate and timely actions, where warranted, is inherently tied to its knowledge of the existence and the extent of a device-related problem shortly after it occurs. For this very important task FDA relies on the users of the devices (eye care practitioners in the case of ophthalmic devices).

Thus, it is of utmost importance that the ophthalmic community understands how, when, and where it should report potential problems. FDA relies on these reports to maintain safety surveillance of all FDA-regulated devices. Your reports may be the critical action that prompts a modification in use or design of the product, improves the safety profile of the device, and leads to increased patient safety.

Monitoring and understanding AEs

The FDA monitors post-market AEs through both voluntary and mandatory reporting. Voluntary reporting to the FDA began in 1973. It was not until 1984 that the FDA implemented mandatory reporting, per the Medical Device Reporting (MDR) regulation.

This regulation required device manufacturers and importers, as they still do today, to report device-related deaths, serious injuries, and malfunctions to the FDA. Additional legislative initiatives have resulted in significant changes to mandatory reporting. User facilities (hospitals, nursing homes, ambulatory surgical facilities, outpatient diagnostic and treatment facilities, ambulance services, and health care entities) are required to report deaths to the FDA and deaths and serious injuries to the manufacturer. These requirements are summarized below in Tables 1 and 2.

The FDA recently established a network of 350 user facilities (primarily hospitals) to enhance our understanding of AEs in the clinical environment in which they occur. This Medical Product Safety Network (MedSun) provides enhanced reports of AEs and a platform for discourse and resolution of important safety issues (e.g., via periodic audio conferences).1

To better understand reporting of AEs under the current MDR regulations governing mandatory reporting, I will define some of the key terms:

• Serious injuries: Life-threatening events that result in permanent impairment of a body function or permanent damage to a body structure; events that require medical or surgical intervention to preclude permanent impairment or damage.

• Malfunctions: Failure of a device to meet its performance specifications or otherwise perform as intended.

•Device-related: The event was or may have been attributable to a medical device, or that a device was or may have been a factor in an event, including those occurring as a result of device failure, malfunction, improper or inadequate design, poor manufacture, inadequate labeling, or use error.

There are several guidances currently available about Medical Device Reporting (MDR) which can be found at


Voluntary reporting

Voluntary reporting to FDA of device-related problems is a critical professional and public health responsibility. Currently, voluntary reporting takes place under MedWatch, a program created in 1993 to encourage voluntary reporting by all interested parties.2

MedWatch allows health care professionals and consumers to report serious problems that they suspect are associated with the medical devices they prescribe, dispense, or use. Reporting can be done on line at, by phone (1-800-FDA-1088), or by submitting the MedWatch 3500 form by mail or fax.

Since its inception in 1973, the FDA's database of voluntary and mandatory reports of device AEs has received approximately 1.5 million reports and currently averages about 180,000 per year. Mandatory reports account for close to 95% of the total.

The reports capture information on device specifics (e.g. brand name, model number), event description, pertinent dates (e.g. event date), and patient characteristics. Manufacturers also supply methods, results, and conclusion codes relevant to their report investigation.

The staff of clinicians and engineers review the individual reports from a variety of perspectives: the potential for device failure (e.g. poor design, manufacturing defect); use error (e.g. device misassembly, incorrect clinical use, misreading instructions); packaging error; support system failure; adverse environmental factors; underlying patient disease or co-morbid conditions; idiosyncratic patient reactions (e.g. allergy); maintenance error; and adverse device interaction (e.g., electromagnetic interference).

Several immediate actions, aside from routine requests for follow-up information, may be taken by the staff. These include:

Recommending directed inspections of manufacturers. These may lead to: (a) label changes, including those affecting device instructions or training materials, (b) product modification/recall, and (c) product seizure or injunction (rarely).

Recommending internal expert safety meetings. These may lead to public notifications, recommendations for additional post-market study, or meetings with the company to explore issues further.

Alerting regulatory authorities outside the United States through the international vigilance program (a program that allows for sharing AE information among regulatory authorities).

Other internal uses of the AE data are widespread and include: input into pre-market review (by providing human factor insights and information on product experience in the general population); input into recall classifications (involving a hazard evaluation based on AE data); monitoring of recalls (and assessing reports in similar products); input into product reclassifications and exemptions from pre-market notifications (based, in part, on a product's safety profile); use in, and initiating of, standards efforts that establish device performance; educating the clinical community through newsletters, literature articles (peer-reviewed and professional and trade journals), and teleconferences; and as a general information resource for healthcare providers and the general public.

I hope that this column gives EyeWorld subscribers a strong appreciation of the importance of reporting medical device-related adverse events in support of FDA’s mission to protect public health. I look forward to thorough reporting by my ophthalmic colleagues.


2.Kessler DA. Introducing MeDWatch: A new approach to reporting medication and device adverse effects and product problems. JAMA 1993;269:2765-8.

Need To Contact The FDA?

GOOD LUCK! These wonderful people have helped me extensively ( NOT! ). If you're expecting help, expect a runaround: - 301-827-2410

Les Weinstein - OMBUDSMAN (CDRH) - – 301-827-7991

Christine Kellerman –SECRETARY (for Les Weinstein) (OA) - - 301-827-7975

Matthew Tarosky - SR SUP REGULATORY O - – 240-276-0243

Linda S Kahan - DEPUTY DIRECTOR CDRH - – 301-827-7975

Everett Beers, Dr. – SUPV GENERAL ENGINEE - - 301-594-2018 x136

Michael Marcarelli – SR SUP REGULAT O - - 240-276-0244

Viola Sellman – SUPV CONSUMER SAFETY OFCR - - 240-276-0125

Barbera Stellar – PUBLIC HEALTH ADVISOR - - 240-276-3150 x144

Timothy Ulatowski – DIR OFFICE OF COMPLIANCE - - 240-276-0100

Joy Lazaroff – SUPVY PARALEGAL SPECIALIST - – 301-827-7258

Ronald Swann - SUPV CONSUMER SAFETY OFCR - - 240-276-0115

Mark Weinstein - Assoc. Dep Dir CBER/OBRR - - 301-827-3518

Gene Allen – PUBLIC HEALTH ADVISOR - - 240-276-3150 x114

Malvina Eydelman - SUPV MEDICAL OFFICER  - - 301-594-2205 x132

Jean Toth-Allen - PHYSICIST - – 301-827-1585

Jerry Dennis – CONSUMER SAFETY OFFICER - – 240-276-3330

Linda Lyons Drager (ODE) – SECRETARY (OA) - – 301-594-2186 x108

Pat Storer – CONSUMER SAFETY TECHNICIAN - - 301-594-2205 x184

Laurie Lenkel – REGULATORY COUNSEL - - 301-827-3390

Steven Kendall - SUPV CONSUM SAFETY OFFICE - - 301-594-1162

Susan Setterberg (phila) - REG FOOD AND DRUG DIR - - 215-597-8058

Ed McDonald (phila) - CONSUMER SAFETY OFFICER – – 215-717-3739 x4524

Steven Kane (phila) - CONSUMER SAFETY OFFICER – – 215-717-3718

Ronald Stokes (phila) - CONSUMER SAFETY OFFICER – – 215-597-4390 x4533

No longer with the FDA or listed on employee directory:


Lester Crawford 

Mark McClellan 

A. Ralph Rosenthal

Levering Keely –

Harold Pellerite –