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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.
The Autonomous Ladarvision Systems are made by the Swiss-owned healthcare company Alcon and are based on Nasa technology.
When alerted by The Times, a spokeswoman for Boots said that Alcon had not told the company of the alleged problems in America. Boots said it had had no complaints, but it is contacting patients who were treated with one machine that Alcon said in 2001 was from a batch that could develop problems.“It is a concern to us going forward if there are reports of older lasers degenerating,” she said. “If these ophthalmologists in America are voicing concerns, we would want Alcon to let us see that evidence as a matter of urgency.”
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Alcon last night denied that there was a problem with the any of its lasers, even the older machines. A spokesman said the allegations were the result of financial disputes, and any reported problems were most likely caused by surgeon error.
Ladarvision systems, which are used on 10,000 Britons a year, are currently in use in Boots’ nine eye treatment centres, as well as two private clinics in London and Aberdeen.
Alcon is being sued in North Carolina District Court by EBW Laser, a company that acquired ten of its lasers to lease to US clinics. The lawsuit contends that two of the machines were “badly malfunctioning”.
Surgeons have linked the machines to a range of adverse events, including glare, blurred vision and erroneous removal of eye tissue.
Alleged erratic performance of these machines have “necessitated thousands of patients to have their eyes redone, often multiple times,” the documents claim. EBW also alleges that Alcon knew that its device was malfunctioning, but failed to inform doctors.
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An eye surgeon in Washington State, who was sued by Alcon for failing to pay fees on the machines, has also filed a lawsuit against the company, while several other actions are being brought against Alcon by doctors and patients.
It is understood that the doctor also made his allegations to the US Food and Drugs Administration, the regulatory body, in January this year.
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.
“Reports began to come in from doctors that the Autonomous Ladarvision Systems, or some of them, were badly malfunctioning. Sometimes when the machines indicated a sufficient laser cut would be made, no laser cut would be made at all. At other times the cut would be, in any case, greatly different than the machine indicated.”
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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.
The FDA report lists it as an “adulterated” device recalled or subject to field corrections to correct “unanticipated laser pulses . . . which could result in a central corneal defect”.
A spokeswoman for Boots said that it planned to contact 49 patients who had treatment with the London laser before it was mended to check for adverse outcomes.
She said the company was certain that no errors had occurred with its suspect machine, which had always had good re-treatment rates,, “We would like to reassure our patients that our lasers are calibrated before each and every patient,” she said.
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An Alcan spokesman said that the action had been taken to avoid “potential malfunctions”, the FDA had been informed, and the matter had been deemed closed.
Laser surgery, which costs about £1,000 an eye, is currently performed in 92 clinics in Britain on more than 90,000 people a year.
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.