Frequently asked questions

Last updated: December 2004

Q: What is the Alcon LADARVision® ?

The Alcon LADARVision® is an excimer laser originally developed by Autonomous Technologies. It is used by some laser eye surgery centers to perform LASIK, PRK and similar vision correction surgeries. It can be used for either conventional laser treatment or wavefront-guided treatment (the trade name for Alcon's proproietary wavefront-guided treatment is CustomCornea®)

Q: Why has LaserMyEye found it necessary to caution consumers/patients?

We have serious concerns about the performance of many LADARVision devices based upon a combination of publicly available documentation, public and private testimony by surgeons (including some who use the lasers, who used to use the lasers, or who have never used the lasers), and private reports from patients to LaserMyEye about their experiences with complications, adverse effects, and equipment failure/shutdown. We are particularly alarmed at the expert testimony recently given under oath by a former senior FDA official about safety and regulatory implications of the situation based upon the information that he has reviewed.

It is a fundamental principal upheld by LaserMyEye that consumers evaluating an elective vision correction procedure must have access to factual information about the risks they will incur. If serious doubts are raised as to the factuality of the information patients are being given, it is for us a moral imperative to relay our doubts to consumers so that they can exercise due caution in considering the options before them.

Q: How long will this alert remain in effect?

We shall continue to caution consumers about the LADARVision at least until definitive information is in the public domain, including (without limitation) the following:

• retreatment rates on those machines which are alleged to have had retreatment rates in excess of their FDA labelling,
• the incidence of adverse effects which have been alleged to occur more frequently on the LADARVision (including but not limited to overcorrections, decentrations, small effective optical zones - referred to in one medical journal as systematic underablation - and epithelial ingrowth), and
• the incidence of complaints by surgeons to Alcon about suspected poor performance of the devices and/or incidence of the adverse effects aforementioned exceeding the incidence in the device labelling.

Q: What press coverage has there been, and how has Alcon responded?

1. On 28 August 2004 The Times [London] reported about allegations of LADARVision® device faults leading to (a) excessively high percentages of patients requiring additional surgery and (b) damage to eyesight caused by the lasers. More.... Alcon responded with a press release, here.

2. On 21 December 2004, Fox (Chicago) aired a report about these allegations. We have not seen this yet but we have been told that they aired excerpts from the conference call amongst surgeons and Alcon executives which the Times had cited as well, and that they showed excerpts from the alleged leaked document from Alcon showing high retreatment rates at some clinics. Alcon refused to be interviewed for the broadcast but put out a statement which Fox broadcast during the segment. No information about this broadcast appears to be available on the internet as of the last time this page was updated but videotape recordings or transcripts of the broadcast can be obtained from Fox.

3. In January 2005, EyeWorld (the news magazine of the American Society of Cataract and Refractive Surgeons) published a story about retreatment rates on the LADARVision, giving air to views from several sides. More....

Q: How many LADARVision lasers are there? Are the allegations saying that something is wrong with all of them?

According to MarketScope's November 2003 comprehensive report on the refractive market, approximately 10% of the installed base of lasers worldwide in 2003 were Alcon LADARVision® lasers, specifically, 445 units, 320 of which were in the US and 125 outside the US. For further information on individual LADARVision units, click here. As we understand it, the allegations refer to some or many lasers, not all lasers.

Q: How did Boots Laser Eye Clinics chain respond to the Times, and what is the situation there today?

Boots Laser Eye Clinics [owned by the popular drugstore giant Boots plc, and the only large user of the LADARVision in the UK] denied that there was a problem with any of its lasers, but called back 49 patients who had been treated on one of the machines prior to a corrective action in 2001 to ensure they had not suffered injuries. Two and a half weeks after the Times news report, Boots announced it was exiting its dentistry and laser eye businesses. It was further reported in October that Optical Express was purchasing Boots' laser eye clinics. Optical Express have told us they have no plans to use the Boots lasers. This leaves only two clinics in the UK operating the LADARVision. We have heard (whether accurately or no we do not know) that one of them is in the process of replacing it with another make.