The Food and Drug Administration (FDA) first approved the use of lasers for vision correction the 1990s.  By 2008, the administration began to hear patient complaints concerning little-known complications including impaired vision and chronic pain.  These issues were so severe that, according to the patients and their families, they had led to disability, job loss, and depression.  Some committed suicide.  The families of those affected testified at an FDA meeting, but little was done back then.These complaints directly contradict the common misperception that Lasik is not invasive, and therefore, virtually foolproof.  However, truth be told, serious questions remain about both the short- and long-term risks and the complications of this common procedure even though the little-known side effects can be life-changing.Researchers at Ohio State University (OSU) reported in 2007 that while most of the roughly 4,500 patients had achieved 20/20 or 20/40 vision six months after the procedure, twenty percent had dry eyes that were severe or worse than before surgery.  And, a recent clinical trial performed by the FDA found nearly half of all participants who had healthy eyes before Lasik developed visual aberrations after the procedure and roughly one-third developed dry eyes for the first time.The OSU researchers had written, “patients undergoing Lasik surgery should be adequately counseled about the possibility of developing new visual symptoms after surgery before undergoing this elective procedure.”  Yet, not much was done.

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Diana Zuckerman, president of the nonprofit National Center for Health Research said, “The FDA keeps promising to do a better job of post-market surveillance, but there is no evidence of real improvement,” she said.Lasik surgeons, meanwhile, continue to assert that soreness, dry eyes, double vision and other aberrations subside within months for most patients and serious complications are extremely rare.“Do bad outcomes sometimes occur?  Yes.  But the risk is extremely low,” said Dr. Eric Donnenfeld, a past president of the American Society of Cataract and Refractive Surgery.Surgeons also frequently point to the procedure’s popularity as evidence of its success and low complication rate.  Lasik eye surgery was conducted on some 700,000 eyes in 2017, up from 628,724 in 2016.A group of patient advocates is now demanding the FDA issue public warnings about Lasik.  The group is headed by Dr. Morris Waxler, a retired senior FDA official who regrets the role he played in Lasik’s approval all those years ago and Paula Cofer, a patient-turned-advocate who says Lasik destroyed her eyesight and left her with chronic pain.  Cofer now runs a website, lasikcomplications.com.One patient who experienced the little-known complications was Max Burleson Cronin, who underwent Lasik surgery in 2014, two years before he committed suicide.  After the surgery, his vision deteriorated to the point he could not see at night or read on a computer.  He was also in constant pain.  He left a note that said, “Doctors destroyed my eyes, and ruined my life,” according to his mother, Dr. Nancy Burelson.“It’s a nightmare no parent should go through, all for an elective procedure,” she said.“We want the F.D.A. to warn the public that Lasik injures eyes and causes pain, vision problems and other persistent problems that cannot be solved — and that you don’t get these problems from glasses or contact lenses,” said Dr. Waxler.

Sources:

Blurred Vision, Burning Eyes: This Is a Lasik Success?LASIK Quality of Life Collaboration ProjectLASIK Eye Surgery May Cause Complications For 45% of Patients: FDA