By Alaina Demopoulos

Surgeons view Lasik as routine, but patient advocates and some experts say the complication rate is far higher than reported.

Until last year, Robin Kyle Reeves lived an active life in Laurel Hill, Florida. She made lace gowns for children to wear during baptisms or family portraits. It was intricate work that requires precision, and Reeves’ glasses kept getting in the way. So her doctor recommended Lasik.

The procedure, which uses lasers to cut in and reshape a patient’s eye, was billed as simple and quick, usually done in under 30 minutes. “It was supposed to be zip, zap, and within a couple of weeks you’re healed and life goes on,” Reeves said. “But my life has stood still since July 12 of last year.”

According to Reeves, the procedure left debris behind her corneal flap, which ruined her eyesight and causes double vision, intense migraines and eye strain. She finds it impossible to stare at screens for an extended period of time, and can no longer enjoy her hobbies. She quit her job and had to repay deposits when she realized she could no longer focus on sewing.

“It puts a big dent on our household income,” Reeves said. “My head hurts all the time, and I can’t do normal activities. Simple things, like reading a box of mac and cheese, or putting on the same makeup I’ve applied for 40 years – I just can’t do that.”

Reeves is one of the 500,000 Americans who undergo Lasik every year to correct their vision (about 100,000 people in the UK have the surgery annually). Surgeons who perform Lasik view it as routine, touting surveys promising a customer satisfaction rate of 90% to 95%. Surgeons who perform Lasik must have the standard board certification in ophthalmology and it is recommended that a patient choose one with a one-year accredited fellowship in refractive and cornea surgery. That extra step is not necessary to perform Lasik, but specialists who have it are more likely to get referrals from other generalists.

The American Refractive Surgery Council says the procedure’s complication rate is less than 1% (though 30% of people may see short-term side effects like dry eyes). Doctors also say that using new lasers significantly decreases complications, compared with the older-generation models that were used in the early 2000s.

But patient advocates and some experts say that is not the full picture. Dr Morris Waxler, a retired FDA adviser who voted to approve Lasik in the 1990s, is now one of its biggest critics. He says he regrets his role in bringing the procedure to the public.

According to his own analysis of industry data, the complication rate of Lasik falls between 10% and 30%. One investigation of an FDA database by the reporter Jace Larson found more than 700 complaints of severe pain, described as “worse than childbirth” or as if “their eyeballs would stick to their eyelids almost every night”.

Last year, the FDA released draft guidance telling doctors that prospective patients should be warned they might be left with double vision, dry eyes, difficulty driving at night, and persistent eye pain.

In one clinical trial from 2017, the FDA found that nearly half of participants reported experiencing “new visual symptoms” after undergoing surgery. Those effects can show up as the presence of glare, halos, or starbursts, especially at night.

The guidance is not final; a spokesperson for the FDA said that the agency was currently in the process of considering hundreds of public comments submitted on the draft guidance. Those comments include strongly worded rebuttals from ophthalmologists who say the procedure changes lives for the better, and regretful patients who wish they had never gone through with it.

If the FDA ends up issuing this draft guidance as final, it will provide a recommendation – not enforced – on how surgeons should inform patients of potential risks.

According to the draft, doctors would be advised to share with their clients that their corneal nerves “may never fully recover, resulting in dry eyes and/or chronic pain”, and that there have been reports of some patients who have experienced depression or suicidality they believe to be a result of the fallout from Lasik. (The FDA notes that “a definitive causal link between Lasik and these reported psychological harms has not been established”.)

Paula Cofer, from Tampa, Florida, who testified in front of the FDA in 2008 and 2018, said her experience had started with visual symptoms. Cofer paid about $1,000 in 2000 for the procedure, which she knew next to nothing about at the time, other than that it was her ticket to a life in which she no longer needed glasses.

But she started to notice complications almost immediately: the first night she went out and looked at the moon, Cofer saw eight overlapping circles smeared with a “ghastly” halo around it. “It looks like something out of a horror movie,” she said. Now, she lives with severe dry eye and bad night vision. She owns four pairs of glasses to make up for the eyesight she’s lost.

Cofer is one of the loudest critics of Lasik. She runs a Facebook support group with over 8,000 members who swap stories of their post-op ailments. “There is an epidemic of Lasik complications,” Cofer said. A number of people on the group claim Lasik has led to them having severe mental health issues.

In 2019, a Florida car dealership comptroller named Gloria McConnell asked her eye doctor for a new glasses prescription. According to her son Kingsly Alec McConnell, she had recently undergone Lasik surgery, which had fixed her problems seeing from a distance. But she still dealt with farsightedness, and thought a pair of readers might help. During the appointment, McConnell’s doctor talked her out of the idea, and she decided to try one more attempt at Lasik to fix everything.

Four years later, after experiencing debilitating complications from the procedure that left her unable to leave bed most days, McConnell died by suicide at the age of 60. Her son said that in a note she left to her family, McConnell wrote that the pain of the botched Lasik surgery had contributed her decision to end her life.

Kingsly describes his mother as fun and youthful before she had the surgeries.

The complications crept into McConnell’s life a few weeks after her surgery, but she tried to stay positive. Still, as things continued to grow worse, she became a shut-in, Kingsly said.

Her main issue was chronic dry eyes, to the point that she told people it felt like her lids were burning. She also suffered from corneal neuralgia, which is caused by damage to the nerves of the cornea. She had mites and ingrown hairs in her eyelashes and inflammation of her eyelids and spent most of her day lying in bed with her eyes closed.

“The pain affected her whole head,” her son said. “She did not take her life randomly or in the heat of the moment. In a way, it was a rational choice for her: why would you live a life so full of suffering?”

McConnell submitted a comment on the FDA’s draft guidance in November. “[Lasik] has destroyed my life,” she wrote. “My doctor told me I was the perfect candidate for Lasik and never talk[ed] at all about the risk … please help people like me.”

Would a stronger warning from doctors help reduce complications from Lasik? Waxler, the former FDA adviser, thinks that the FDA’s proposed guidelines are “very mild”.

“After 30 years, the FDA has finally decided that maybe they should require refractive surgeons and manufacturers to tell their customers a little more about the downsides of Lasik,” he said. “If surgeons told people of all of the possibilities of getting complications, they wouldn’t have any customers.”

Dr Cynthia MacKay, a retired clinical professor of ophthalmology at Columbia University medical school, worked alongside Stephen Trokel, who was the first ophthalmologist to recognize the significance of the laser used in corneal refractive surgery.

“I thought it would never catch on,” MacKay said. “If you slice into the cornea to change its shape, you’re going to cut through all of the nerves that feed the cornea and keep it healthy, which will result in terrible pain,” she said.

Giving patients consent forms, as the FDA’s draft guidance recommends, is not enough for MacKay. She has worked as an expert witness in Lasik malpractice cases and has seen shady behavior from surgeons who give patients such forms right before their procedure, when they’re under anesthetic and trying to read the paperwork while their pupils are dilated.

“I think Lasik should be banned,” MacKay said. “It’s a public health hazard. There’s an epidemic of pain and blindness all over the world [because of this procedure].”

Most ophthalmologists who perform Lasik say that is simply not the case. The surgery is not without complications, but it is rare for any extreme issues to arise. One paper has found that the majority of Lasik recipients were happy with their results, with only 1.2% reporting dissatisfaction. (Most studies are written by surgeons who perform the procedure themselves and may be biased.)

“I had Lasik on my own eyes about 20 years ago and it was one of the best things I have ever done for myself,” said Dr Sidney Gicheru a spokesperson for the American Academy of Ophthalmology and medical director of LaserCare Eye Center in Dallas.

“A large majority of people who have had Lasik report being satisfied with their improved vision and the ease they now enjoy in their day-to-day lives,” Gicheru added.

All of which only adds to the confusion for prospective patients. Will Lasik change your life for the better, or worse? Concerned perspective patients may find themselves sifting through opposing data or online forums before making their decision.

Gicheru, who performs the procedure, said it helps to know whether or not a patient will be a “good candidate”. It is not for everyone. There are a few boxes you have to check: being over 18, with an eye prescription that has not changed in the last year. Patients who experience severe dry eye, corneal disease, advanced glaucoma, or diabetes that is not controlled well should seek other options. Those who live with astigmatism or are near or farsighted should also consult their ophthalmologists first, and may see better outcomes with other forms of surgery.

Dr Edward Manche, a professor of ophthalmology at Stanford University, recommends that patients seek out one or two opinions from surgeons before they decide to go through with the procedure and advised that patients stay away from clinics that overly advertise Lasik. “The vast majority of centers that do the surgery are extremely ethical and try to do the right thing,” he said. “But if a center feels like it’s giving you a sales pitch, and seems more like it’s doing business rather than looking out for your best interest, that’s a red flag.”

Reeves, one of the Facebook group members, no longer drives a car. When she needs to go somewhere, she enlists a family member to get behind the wheel. “I can’t take myself to do something as simple as getting bread, milk, cheese, or eggs,” she said.

Shortly after her botched surgery, Reeves returned to the clinic for an appointment to discuss her complications. The doctor told her he could try another round of Lasik, but she refused. Reeves still remembers sitting in the waiting room of the clinic, watching a revolving door of patients go in and out for their procedures.

“It took everything in my being to sit there, be quiet, and not tell them, ‘This is not an easy, in-and-out thing the way they make it out to be,’” Reeves said. “I wanted to say, ‘This could change your life for ever.’”