FDA warns that LASIK surgery patients need to be better informed of risks

The surgery known as LASIK — Laser-Assisted In Situ Keratomileusis — is under the lens of the Food and Drug Administration (FDA), which is causing controversy among eye experts. 

The FDA released a 25-page draft guidance after receiving input from patients who felt they were not fully informed of the risks associated with the surgery, the agency stated on its website. 

The FDA’s guidance states that patients considering LASIK surgery should be given a “decision checklist” that describes the procedure.

Patients should also receive a list of potential side effects that may include dry eyes, difficulty driving at night, double vision, seeing halos around objects and in some cases persistent eye pain and a need for glasses, the FDA said in the same paper. 

The FDA in July presented the draft guidelines, which suggested the content that should be included on patient labeling information for LASIK devices.

“It is important for people considering LASIK to have clear and understandable information on the benefits and risks of the surgery to help inform their decision on whether to get LASIK,” the FDA said in the draft guidance. 

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

“Further,” the agency noted, “this information is intended to enhance, but not replace, the physician-patient discussion of the benefits and risks of LASIK devices that may uniquely pertain to individual patients.”

LASIK is a surgery that takes less than 30 minutes to perform; its purpose is to correct vision problems such as nearsightedness, farsightedness and astigmatism. It’s not typically covered by insurance and can cost several thousands of dollars. 

The goal is to reduce a person’s dependency on eyeglasses and contact lenses, the FDA said on its website. 

The surgical procedure, said health care experts, uses a type of laser to permanently change the shape of the cornea, which is the covering of the front portion of the eye that refracts light. 

One eye surgeon from New York told Fox News Digital that it is a “very rewarding procedure to perform, as it tremendously improves the quality of life and reduces the risk of contact lens-related complications.” 

Dr. Kira Manusis, M.D., a corneal surgeon at New York Eye and Ear Infirmary of Mount Sinai Health System in New York City, told Fox News Digital that LASIK surgery has been around for over 25 years. 

Manusis, an ophthalmologist, said her practice provides patients with a multi-page consent form and a video to watch prior to the procedure, to further ensure that the patient is making an educated decision.

The surgeon explained, “Over this time we have learned a lot about the risks but also enormous benefits of laser vision correction as compared to contact lens overwear and contact lens-related infections. We refractive surgeons have to do even better at screening patients who may not be candidates and have potential side effects, such as those who have underlying dry eye even prior to Lasik.” 

Although the federal agency report sparked some controversy within the profession — with some professionals calling for a withdrawal of the draft recommendations — Manusis said the “FDA’s review demonstrates a very low-risk profile and complication rate of LASIK, but the small percentage of patients experiencing post-operative side effects cannot be overlooked.”

She added, “As with any other surgical intervention in every field, no procedure is risk-free, and this needs to be clear to our patients and the general public. Risks should be clearly stated in the consent form — and appropriate discussion needs to take place.”

Concerns about informing the patient 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 back in May 2009, providing information regarding promotion and advertising of FDA-approved lasers used during LASIK. 

The FDA said that since then, it has received additional complaints that eye care professionals failed to inform patients of indications and the risks and limitations associated with LASIK procedures. 

The agency said it sent another letter in 2011 reminding eye care professionals of their legal responsibility to provide balanced information to their patients. 

The FDA said a letter was also issued to the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology that provided additional information about informing consumers about the risks of LASIK in eye care professionals’ advertisements and promotions.

The FDA collaborated with the National Eye Institute and the Department of Defense to conduct research and in 2009 launched the LASIK Quality of Life Collaboration Project to help better understand the potential risk of problems that can occur after LASIK. 

Part of the project included creation of a patient reported outcome tool questionnaire. 

The agency collected data about side effects that patients experienced post-op — but also acknowledged that over 95% of participants in one study it did said they were satisfied with their vision following LASIK surgery.

The July draft guidelines suggested informing patients about potential side effects.

Those included the possibility that six months after surgery, up to 27% of patients may experience dry eye symptoms; approximately 41% of patients may experience visual symptoms such as glare, halos, starbursts, and double images (with or without glasses, contact lenses); around 4% of patients may have “very” or “extremely” bothersome symptoms; and around 2% may have “a lot of difficulty” or can no longer perform usual activities. 

The FDA draft was issued in July 2022 and the FDA accepted over 640 comments about the suggested draft guidelines from professionals, associations and individuals through Nov. 25, 2022. 

Reactions were mixed. Some said the guidelines were needed, while others expressed concern that the document appeared to be one-sided, focusing on the risks that will frighten patients from undergoing the procedure.  

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

“The academy believes that effective informed consent is a process of shared information and decision-making that happens between the physician and the patient. A discussion of risks and benefits can sometimes seem abstract, and for it to be meaningful to an individual, they must be interpreted and discussed specifically for that person taking into account their unique features and needs. We are also concerned that there are several statements that are not well-supported by the latest evidence, and some that have actually been disproved.” 

One ophthalmologist who performs refractive surgery in Beverly Hills, California, posted on the FDA draft guideline comments section that “LASIK has been the single best decision I have ever made in my entire life.” 

The physician continued and warned, “It is important not to stigmatize LASIK and thus deny its enormous benefits to a wider audience.”

This professional added, “Modern LASIK is significantly better statistically than the procedure that was performed on me. The screening techniques and laser machines have been dramatically improved, which has dramatically improved the safety and enormously decreased the patient complaints, which are very rare and typically very mild. A balanced viewpoint, that emphasizes the benefits and risks, is necessary — not fear-mongering!”  

Dr. Robert Layman, O.D., president of the American Optometric Association (AOA), headquartered in St. Louis, Missouri, and representing more than 48,000 doctors of optometry, optometric professionals and optometry students, posted a comment in a letter to the FDA commissioner that said, “As steadfast supporters of ensuring that patients receive fully transparent information on the risks and benefits of LASIK devices, the AOA believes this guidance to be timely and beneficial.” 

One patient from Long Island, New York, who wears contacts and glasses, told Fox News Digital that the more information provided to patients, the better. 

The patient, a male in his 50s, said he considered getting the procedure and told Fox News Digital he’s glad the FDA issued the draft guidelines. 

“There seems to be so many of these LASIK clinics in my community that it is hard to discern which are reputable. One doctor made it seem like it is a simple procedure with not many risks,” he said.

He added, “The draft made me more aware of side effects and I think it is important because now I can now make a fully informed decision,” the man told Fox News Digital. 

Manusis told Fox News Digital she does not believe it will be the case that patients shy away from the procedure. 

“It is a very successful procedure, hence the number of people getting it annually. I do not think it will deter those who are good candidates.”

The FDA document is not final. 

The agency said the next step is to weigh all the comments before preparing a final document.