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August 28, 2004

Fears that grew over 'perfect' operation

This article is subject to legal complaint

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, Herman Sloane, 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 Sloane said.

At the end of the conversation, Mr Sear, the British former head of the Swiss-owned company, based in Texas, thanked the doctors for raising issues “which we take very seriously”.

Yet to date at least two of the doctors’ concerns remain unresolved and the company continues to deny that machine malfunction has ever been a legitimate problem. They say that the complaints are being fabricated by doctors and companies trying to avoid paying bills to Alcon.

According to the US Food and Drug Administration, the country’s regulatory body, the manufacturers of medical equipment are required to report any adverse effects that occur “with unexpected severity or frequency”.

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.

In papers responding to the EBW claims, Alcon describes the charges as a “litany of unfounded accusations”. It refers to the “loaded language and invective” of the legal brief as “not a substitute for the requirements imposed by law”.

Brian Will, a Canadian surgeon, makes similar allegations to EBW about laser unpredictability in documents that have been filed in Washington State courts.

In January, Alcon won its suit against Dr Will for breach of contract and for non-payment of $1.6 million in fees.

The physician claims that he defaulted on the payment after obtaining leaked Alcon data showing high retreatment rates in other clinics using Ladarvision lasers.

He is appealing in the Court of Appeals of the State of Washington on the ground that Alcon withheld relevant documents.

While some doctors have kept with Ladarvision systems, others — despite Alcon’s assurances — still contend that little or no action was taken and the £300,000 machines continued to be linked to adverse events.

Sheri Rowen, an eye surgeon in Baltimore, said that her laser had also started to malfunction. She plans to launch a lawsuit against Alcon early next month.

“I asked Alcon if other doctors had experienced problems with their lasers and their results and they told me no, and they seemed to attribute my concerns to everything but the laser itself,” she told The Times. “They also told me that my laser was operating properly when it wasn’t.”

Ms Rowen said that she no longer used that model of the laser. “I changed my laser technology — and I would never be comfortable using the Ladarvision platform again . . . There used to be three Ladarvision in my city — now there are none. That says it all.”

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”.

In Britain, machines used in Boots clinics had rates of around 10 per cent at the end of 2002, double the number of patients of 2001, the first year using the system.

A spokeswoman for Boots said that last year 8 per cent of patients had retreatments, which were nearly all “tiny little tweaks”. She added that 99 per cent received 6/12 vision — the equivalent of driving without glasses — after one operation.

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

An Alcon spokesman said that retreatment rates were not a good indication of alleged machine fault. “If there was a consistent problem, then all the systems would have similar issues,” he said. He said that it was never Alcon’s position to conceal problems from doctors, adding that all lasers had been passed by the FDA. “We are not going to threaten our standing with the ophthalmic community by hiding things from them.”

An FDA spokesman declined to say if it was investigating the safety of Ladarvision devices. He said that the agency knew of allegations against Alcon, but was “not aware” that Alcon has reported any increase in retreatment rates.

Rebecca Petris, a campaigner for greater eye surgery regulation who runs the website LaserMyEye, said: “If the only way to protect patients is by removing the Ladarvision from service until this is thoroughly investigated, then that should be done.”


  • An operation known as Lasik (Laser Assisted in-situ Keratmileusis) for near-sightedness is the most common form of laser eye surgery used in Britain. It costs around £1,000 per eye

  • The patient is asked to lie on a couch beneath the laser and is given eyedrops that contain a local anaesthetic

  • A small device, known as a speculum, is used to keep the eyes open and the patient is asked to look up at a small, blinking light

  • A suction ring is placed on the eye to stabilise it. For the minute or two that this is in place, the patient is not able to see

  • An automated surgical instrument containing a very fine blade is fitted to the suction ring and passes over the eye cutting a thin flap about a quarter of the way into the cornea. This takes less than 20 seconds. The suction ring is then released and the patient’s vision returns

  • The hinged flap of cornea is then lifted to one side and the laser begins to operate. When the correct amount of cornea has been removed — after about 30 seconds — the eye is washed to remove any particles that may have landed on the exposed surface

  • The corneal flap is then gently put back in position, where it should settle firmly within five minutes

  • The patient should wear clear lens glasses or sunglasses to protect the eyes for two weeks, and eyedrops have to be applied several times a day for a week

  • Most people will experience some minor discomfort for 12 hours, but within this time the eyesight should improve rapidly and be adequate for work within four days

  • There is often some temporary “overcorrecting”, in which short sight becomes long sight, but this will usually settle down within a few weeks. The vast majority of operations pass off with no ill-effects

  • Steven Trokel, a New York City ophthalmologist, performed the first laser surgery on a patient’s eyes in 1987

  • The first laser eye treatment clinic using Dr Trokel’s laser was founded by US-based investors in Toronto, Canada, in 1989

  • The first British clinic was opened at Clatterbridge hospital on the Wirral in January 1991

  • Today, laser eye surgery is a mainstream treatment used on around 100,000 people each year

  • Celebrities including Cilla Black, the former Spice Girl Mel B, Nicole Kidman and Brad Pitt have all had the operation

  • Complaints against laser eye surgeons have increased by 166 per cent in six years and account for a third of all claims against opthalmic surgeons, according to the Medical Defence Union, Britain’s largest insurers of doctors
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