LASER EYE SURGERY 2

High street chain Boots contacted patients who had laser eye surgery at a clinic amid fears the equipment used could be faulty. Boots said it is looking into the claims "as a matter of urgency" but believes its equipment is safe. The move follows reports of legal action in the US. A lawsuit filed there claims some of the Autonomous Ladarvision Systems, which are used in Boots' nine eye treatment clinics across Britain, can develop faults leading to blurred vision.

The laser machine used in Boots' London eye surgery clinic in Regent Street was said to be from a batch identified in 2001 by Swiss-owned health care company Alcon as potentially having a problem. The machine was modified by the laser manufacturer after concerns were raised, a Boots spokeswoman said.

A statement from Alcon claimed the allegations made in the US lawsuit were "completely unsupported by scientific or legitimate evidence". The statement added: "The Ladarvision is safe and effective. It has been extensively tested in clinical trials and was approved for its intended use by the US Food and Drug Administration and other regulatory bodies around the world."

Around 49 patients who were treated with the London laser before it was modified are being contacted by the company to discover if they have suffered any adverse effects. A Boots spokeswoman said, "There have been allegations that much older lasers may have been reported as having problems. We are looking for evidence of that from Alcon. However, we have no reason to suspect any problems with our lasers in the UK. There is no reason to worry."

The company is being sued in North Carolina District Court by EBW Laser, which acquired 10 of its lasers to lease to US clinics, and alleges that two of the machines were "badly malfunctioning". In its statement Alcon said it looked into the machines' success rate voluntarily to prevent potential misfunctions. Laser surgery costs £1,250 an eye at Boots' clinics, and is performed on around 100,000 people each year in Britain.

Negligence claims involving laser eye surgery against doctors belonging to the Medical Defence Union (MDU) have more than doubled in the last six years. The MDU, which is the largest insurer for UK doctors, said that while some of the claims were over faulty surgery many more centred on patients' "unrealistic expectations" about what could be achieved. The figures, released by the union, show that claims over laser eye surgery have increased by 166% in six years, and now account for a third of all ophthalmology claims.

The MDU has increased its subscription rates for laser eye surgeons and advised them how to minimise the risk of a claim. About 100,000 people who are tired of wearing glasses or contact lenses undergo corrective laser eye surgery in the UK every year. The procedure, which was introduced in the early 90s, can cost thousands of pounds. Consumer experts warned that patients undergoing laser eye surgery were not being told about the risks they could be taking with their sight.

The investigation by Health Which? also revealed any doctor could carry out the treatment after just a few days of training, no specialist qualifications were needed. The magazine also found complication rates varied between surgeons and clinics. Earlier, the medical journal Ophthalmology said the failure rate for eye surgery was one in 10, not the one in 1,000 figure widely advertised. Rebecca Petris is one patient who found surgery did not fix her vision.

She said, "I can no longer drive. I've difficulty reading at most distances. I've severe double vision. My night vision is just about gone. It's very difficult to see in dim light or dark circumstances." Dr Christine Tomkins, of the MDU, said, "Patients need to understand what the risks are. And they need to think about whether or not the benefits they think they will get from the procedure actually outweigh the risks, in order to decide whether they want to go ahead with it."

In very rare cases, complications can lead to corneal ectasia, where fluid pressure builds up on the eye. Patients can need a corneal transplant to correct the condition. Other complications, though deemed "minor" by clinics, occur "relatively frequently", according to a recent review by the American Academy of Ophthalmology. Patients can experience dry eyes or night vision problems, which can affect ability to drive or work in the evening or in dim light.

Eye surgeon David Gartry said the risks need to be put into perspective. "You can see that something serious happening would be very rare indeed," he said. "But if the surgeon tells the patients they will have perfect vision afterwards and they will throw away their glasses, that raises unduly high expectations." The MDU is advising surgeons that patients must have enough time to ask questions and absorb information before making a decision to go ahead with the procedure.

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