Times reports about LADARVision®

The Times, August 28, 2004

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The Times is subscription only. Please click here to go to their website. If you register, you may then search the archives on LADARVision and you will find the articles (5 in total on that day). The leading article is (as of the time this was posted) available here.

Excerpts from "Eye surgery fears as laser makers sued for millions"

"A LASER eye surgery machine used on thousands of British patients can develop faults leading to blurred vision and damage to eyesight, according to two lawsuits lodged in American courts, The Times has learnt. The lawsuits claim that some of the machines, the same type of which is used in Boots treatment centres throughout Britain, have started malfunctioning, causing “wildly erratic results” and in some cases damage to patients’ eyes."

"In 2002, five doctors described their concerns about Ladarvision in a conference call to senior Alcon executives, including Tim Sear. who was then Chief Executive Officer. In the conversation, a transcript of which has been obtained by The Times, the ophthalmologists said they had not had problems with the lasers at first, but later came inexplicably poor or erratic results."

"The legal action began in 2003 when EBW was sued for non-payment of leasing fees. In a countersuit, EBW alleged that Alcon’s failure to disclose “critical information known to it of widespread malfunctioning machines” at the time the contract was signed constituted unfair trade practice."

"Leaked internal Alcon data, seen by The Times, appear to support the contention that some machines operated erratically between 2000 and 2002. It suggests that in 2002 more than a third of patients had to be re-treated at more than a dozen surgeries."

"The Times has had information from more than 20 doctors in Canada and the US who say that they have had problems with Ladarvision devices. A machine used in Boots’ London eye surgery clinic in Regent Street was one of a problem batch of lasers identified by Alcon in 2001. The machine, which was subject of an FDA enforcement report in America, was modified on site by Alcon in 2001."

"Fears about the lack of the regulation of the industry has led to the formation of a parliamentary inquiry, led by Frank Cook., a Labour MP. The problems linked to Alcon was cited in expert evidence to the inquiry in March."

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Excerpts from "Fears that grew over 'perfect' operation"

"LASER eye surgery, by offering patients near-perfect sight in one quick operation, has become a billion-pound industry, using the latest technology to generate vast profits.

"From the biggest players such as Alcon, a £2 billion eyecare company, to the hundreds of sought-after ophthalmologists, the stakes could not be higher.

"When a number of doctors from across America began to question whether Alcon’s Ladarvision system, a machine using Nasa laser technology, was malfunctioning, the company had two choices. It could have gone public, and recalled the potentially defective model or, like the three wise monkeys, it could see no evil, hear no evil and speak no evil.

"According to lawsuits in the United States, Alcon stands accused of adopting the second position. When a group of eye surgeons approached Tim Sear, the company’s chief executive, in October 2002 to voice their concerns, their unease was not put to rest.

"In a transcript of the conference call, seen by The Times, XXX, an eye surgeon from Illinois, described how his lasers had been 'unbelievably good' at first, but had begun to fluctuate badly. He said the number of patients he was having to re-treat had subsequently decreased, but he still '(got) a surprise now and again'.

"The doctors said that some had reported that some of their patients had been left with astigmatisms and suffered ghost images, debilitating glare and blurred vision.

"'As it sits right now, I am not comfortable . . . I started with a laser that was nearly perfect in my hands and I still haven’t recovered to my baseline,' Dr XXX said."

"In court documents, EBW, the company that used to lease the Ladarvision machine and which is locked in litigation with Alcon over unpaid bills, baldly alleges that the optical firm repeatedly told individuals who reported a laser problem that it was the first time they had heard of it."

"Alcon suggested instead that the doctors’ surgical skills or factors such as humidity were at fault, it is alleged."

"Although there are no industry standards for rates of retreatment, also known as 'enhancements', industry literature cites a normal level of between 6 and 8 per cent of patients. According to leaked Alcon data used in the EBW case, and seen by The Times, more than 40 per cent of patients at five clinics in the United States had to return for further surgery in 2002. A further 11 had rates over 30 per cent and 39 clinics had rates over 20 per cent. A spokesman for Alcon said that the data was a financial document, and of 'no clinical relevance'."

"To date, Alcon categorically denies that machine error could have caused the reported problems with their American models."

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