http://www.prweb.com/releases/2005/2/prweb205729.htm

FORT WORTH-MADE LASIK SURGERY MACHINE UNDER FIRE

MORE PATIENTS CLAIMING 'LASIK CASUALTY' STATUS

Feb 3, 2005 9:20 pm US/Central
By Investigator Ginger Allen
Producer/Photojournalist: Dave Manoucheri

At the turn of the millennium, it was the wave of the future--Peel back the lens of your eye, and look forward to sight you never imagined. It is the possibility of regaining 20/20 vision. Sandra Brown saw hope.

Three years ago, Brown had Lasik surgery. The pediatric eye surgeon was well aware of the risks associated with the surgery, having studied ophthalmology for more than a decade herself. But five or six months later, the common side effects had not disappeared.

“I turned out to be a disaster”, Brown says, “I have all the characteristics of a Lasik casualty”. To this day, she says she sees halos, ghosting images, and starbursts around lights that make driving at night almost impossible, she says all as a result of a LADARVision laser - made by Fort Worth based Alcon Labs.

Today she has to wear her contacts and her glasses for some activities, and she still feels the side effects of the surgery. It led her to do a case-study on herself.

“Most of the laser that was supposed to hit and flatten my cornea missed,” Brown said.

Her published findings match what an edition of “Eye World” medical journal, several lawsuits, and doctors all over the world are reporting - that between 2000 and 2002, the LADARVision laser . . . at times . . . had a high rate of failure, and/or removed too much eye tissue.

“The laser, unbeknownst to surgeons, have performed sporadically, erratically and in a manner which have produced unpredictably bad results,” says Joel Fineberg, Brown’s attorney. Brown is now suing the Fort-Worth based Alcon.
According to F-D-A reports and court documents, hundreds of patients suffered permanent blurred vision, glares and halos, and or the need for additional surgeries to improve their vision.

So was the Fort-Worth Based Alcon aware of the concerns?

Three doctors have independently told CBS 11 News that they had reported the problems to Alcon early on and stopped using the machines. One doctor said he had spoken out about concerns at national seminars.
CBS 11 has also obtained a transcript of a phone conference where several surgeons tell Alcon Adminstrators they’ve reported their concerns over malfunctions. They say their concerns have been “ignored” and that they are “not comfortable with the laser.”

Alcon would not grant an interview but issued a statement instead:

"Alcon is the world’s leading eye care company with affiliates in more than 70 countries around the world. Alcon Laboratories, Inc. has its headquarters in Fort Worth, Texas. Alcon was founded in 1945 and today has 12,000- employees worldwide, including 4,000 employees in the Dallas/Fort Worth area and throughout the state.

"In 2000, the company acquired Summit Autonomous, and its LADARVision 4000 laser, to expand its comprehensive offering of ophthalmic surgical products. Today, more than 250 lasers are in use in the U.S."

The statement continued:

"The LADARVision 4000 is safe and effective and was approved by the U.S. FDA and other regulatory authorities around the world following carefully conducted clinical trials. In addition, numerous peer-reviewed studies published in respected medical journals since the approval confirm the safety and efficacy of the LADARVision 4000. Alcon’s lasers are manufactured and maintained to the highest quality standards in the industry to allow physicians to provide the best possible visual outcomes for laser refractive patients. Alcon also provides clinical support and resources to assist surgeons in the pursuit of quality outcomes for their patients.

"Due to Alcon’s commitment to patient safety and standard operating procedures for ensuring the quality performance of its products, the company initiated two voluntary field actions for the LADARVision 4000. Both of these actions occurred more than four years ago. These field actions, administratively classified as "recalls," were initiated as a result of very few incidents, in which no injuries were reported. The FDA reviewed the actions and deemed them closed.

"Alcon is aware of allegations regarding the LADARVision 4000 laser made by former customers, who have been sued by Alcon for non-payment of multi-million dollar debts. These allegations are false, inaccurate and not based on any scientific or clinical evidence. Alcon is recognized in the eye car industry for its long-standing commitment to patient safety and to providing the highest quality products to its customers and their patients. As a result, the allegations have not had an impact on Alcon's global sales, production volumes or reputation."

An FDA Spokesperson confirmed the laser is a legally marketed product, which means it is considered safe and effective. She said she was not aware of any action being taken.

The doctors and patients who talked to CBS-11 News for this report all said they still believe in the Lasik procuedure. It was the device they questioned.