LASIK Eye Surgery Patients Warn FDA: More Notice of “Side Effects” Needed

Patients who have had LASIK eye correction surgery — or laser-assisted keratomileusis in situ — have weighed recent Food and Drug Administration (FDA) draft guidelines related to the surgery.

The FDA’s draft has sparked controversy among eye experts — and prompted mixed reactions from patients, too.

The draft is a 25-page report detailing how patients need to be better informed about the risks of potential side effects of the LASIK procedure before surgery.

The FDA WARNS THAT LASIK SURGERY PATIENTS NEED BETTER INFORMATION ABOUT RISKS BEFORE EXPERIENCING AN EYE PROCEDURE

FDA guidelines state that patients should consider LASIK The operation should be given a “decision checklist” that describes the procedure.

Patients should also be given a list of possible side effects that may result from the surgery. These side effects can include dry eyes, difficulty driving at night, double vision, seeing halos around objects, in some cases persistent eye pain, and the need for glasses, the FDA said in the same publication.

FDA guidelines state that patients considering LASIK eye surgery should be given one "decision checklist" that describes the procedure.

FDA guidelines state that patients considering LASIK eye surgery should be given a “decision checklist” that describes the procedure.
(iStock)

Boris A., of Los Angeles, Calif., told Fox News Digital this week that his “eyes burned for a full month after his LASIK procedure and… [he] had to use eye drops daily and couldn’t stand the sunlight or anything [of] White color.”

The California resident said if he could go back in time, he would never have had the procedure performed.

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At first, he said, the surgery seemed to work.

“At this time [after the surgery]yes…I could see clearly in those 15 years.”

He said that eventually he “lost my 20/20 [vision]. I’m wearing prescription glasses again.”

A California resident told Fox News Digital that if he could turn back time, he would never have had the LASIK procedure.

A California resident told Fox News Digital that if he could turn back time, he would never have had the LASIK procedure.
(iStock)

A typical day for him, he said, involves putting multiple eye drops in his eye twice a day because he has dry eye. (His last name is omitted for patient privacy.)

When asked by Fox News Digital if he felt he was fully briefed on possible side effects prior to the surgery, he simply replied, “No.”

“Benefits and Risks of Surgery”

The FDA submitted the draft guidance in July that proposed the content that should be included in patient labeling information for LASIK devices.

“It is important that people considering LASIK have clear and understandable information about the benefits and risks of the surgery to make their decision on whether to receive LASIK,” the FDA said in the draft guidance.

The FDA also accepted comments from the public, individuals and groups associated with ophthalmology, including professionals in the field.

“These recommendations, when finalized, are intended to help physicians share information and understand patients about the benefits and risks of LASIK devices,” the agency also said.

“Additionally,” the agency noted, “this information is intended to enhance, but not replace, doctor-patient discussion about the benefits and risks of LASIK devices, which may relate solely to individual patients.”

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The FDA also accepted comments from the public, individuals and groups associated with ophthalmology, including professionals in the field.

By November 2022, over 600 comments, some positive and some negative, on the draft guidelines had been received.

Patients shared their experiences in the FDA’s comments section — and many of the comments posted there seemed to echo the sentiments of Los Angeles-based Alegria.

"It is important for people considering LASIK to have clear and understandable information about the benefits and risks of the surgery to make their decision on whether to have LASIK," said the FDA in its draft guidelines.

“It is important that people considering LASIK have clear and understandable information about the benefits and risks of the surgery to make their decision about having LASIK,” the FDA said in its draft guidance.
(iStock)

One person posted this comment: “LASIK ruined my life. Please do something against it. Our society needs to know the truth.”

The person added, “My eyes don’t see well at night after LASIK. I have massive ghosting, halos and starbursts. Before LASIK, I had perfectly sharp, distortion-free vision with contact lenses and glasses. I was only 26 years old at the time of LASIK. How sad!”

The same person also felt that there was a lack of information at the time of the procedure.

“My eyes don’t see well at night after LASIK. I have massive ghosting, halos and starbursts.”

“I was assured that the worst case scenario…I would need glasses after LASIK. I wasn’t told that LASIK [would] cause vision problems that glasses and contact lenses cannot correct.”

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The same person added: “I have severely increased floaters in my eyes and sensitivity to light. I’ve spent thousands of dollars on my eyes after LASIK to try and get my old vision back. I wear scleral lenses, which only help a little.”

However, other patients praised the benefits of the procedure.

“I have no regrets about my choice”

The goal of the procedure is to reduce a person’s reliance on glasses and contact lenses by using a type of laser to change the shape of the cornea (the covering of the front part of the eye that refracts light), according to the FDA website .

“My eye surgeon was very reassuring during my procedure, letting me know exactly what was going on and guiding me through it,” said one patient in the report’s comments.

One person wrote in the comments section of the FDA's draft guideline: "The only thing I regret is not having it [the surgery] previously."

One person wrote in the comments section of FDA’s draft guideline: “The only regret I have is not having it [the surgery] previously.”
(iStock)

This person also wrote, “I have no regrets about my decision to have LASIK. The only thing I regret is not doing it sooner. I woke up the next morning and immediately turned on my television to see if I could see what was on.

She also wrote: “I went to lunch and asked my fiancé to ask me what was on someone’s license plate or street sign. I couldn’t believe I could see without glasses or contact lenses. Everything looked like it was HD in there. I would have LASIK again a million times if I could; it has seriously changed my life.”

The procedure takes about 30 minutes and is usually not covered by health insurance.

The procedure takes about 30 minutes and isn’t usually covered by insurance, health experts told Fox News Digital.

Concerns about informing patients early about LASIK risks were raised over a decade ago, according to the FDA website.

The federal agency said it issued a letter to eye care professionals in May 2009 providing information about the promotion and advertising of FDA-cleared lasers used during LASIK surgery.

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The FDA said it has since received additional complaints of ophthalmologists’ failure to educate patients about indications and the risks and limitations associated with LASIK procedures.

“The topics covered in the guide are all important to the informed consent process, but they are not presented with sufficient depth and nuance,” said Dr. Stephen McLeod, CEO of the American Academy of Ophthalmology Academy, based in San Francisco, said in a statement to Fox News Digital.

"Effective informed consent" before the operation "is a process of shared information and decision-making between doctor and patient," said dr.  Stephen McLeod, CEO of the American Academy of Ophthalmology Academy, in a statement to Fox News Digital.

“Effective informed consent” prior to surgery “is a process of shared information and decision-making that occurs between the physician and the patient,” said Dr. Stephen McLeod, CEO of the American Academy of Ophthalmology Academy, in a statement to Fox News Digital.

“The Academy believes that effective informed consent is a process of shared information and decision-making that occurs between the physician and the patient,” McLeod also said.

“A discussion of risks and benefits can sometimes seem abstract, and in order for it to make sense to a person, [the details] must be interpreted and discussed specifically for that person—taking into account their unique characteristics and needs,” McLeod continued.

“They take the money without telling us the future risk,” said one patient in Los Angeles.

“We are also concerned that there are several statements that are not well supported by the latest evidence and some that have actually been refuted,” McLeod added.

However, patients like the Los Angeles man told Fox News Digital the guidelines were necessary.

“Yes, to protect us – as they take the money without telling us the future risk,” he said.

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The FDA released its draft guidance in July 2022.

It accepted over 640 comments on the proposed draft guidelines from professionals, associations and individuals through November. 25th, 2022.

The FDA told Fox News Digital that it will “consider the comments submitted while preparing the final documents.”

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No set timeline was given as to when the final guidance would be released.

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