February 03, 2005

CBS News Airs Report on Malfunctioning Alcon LadarVision Lasers

Fort Worth-Made LASIK Surgery Machine Under Fire
More Patients Claiming LASIK 'LASIK Casualty" Status

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.”

The complete article is available at http://cbs11tv.com/localnews/local_story_035143742.html

Posted by Admin at February 3, 2005 02:55 PM