Although countless people have been able to discard their glasses and contact lenses thanks to LASIK, the eye surgery isn't free of potential risks -- and the Food and Drug Administration wants potential patients to be aware of them before they decide to have their eyes altered.
To that end, the FDA has issued a 25-page report that lists some of the potential side effects, calling for doctors to go over them with patients prior to scheduling surgery.
"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," the report reads. "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 procedure involves changing the shape of the cornea (the clear covering of the front of the eye) with a laser. LASIK surgery is intended to correct common vision problems such as nearsightedness, farsightedness, and astigmatism and to reduce a person’s dependency on eyeglasses and contact lenses.
The FDA says the procedure has been known to cause permanently dry eyes, double vision, persistent eye pain and difficulty driving at night. It can even over-correct a person's vision, leaving them with a need for glasses in spite of having spent thousands of dollars on the surgery, the agency reports.
The FDA also points out that long-term data on the effectiveness of LASIK is not available.
"LASIK is a relatively new technology. The first laser was approved for LASIK eye surgery in 1998. Therefore, the long-term safety and effectiveness of LASIK surgery is not known," the agency said.
The FDA notes that while most patients are very pleased with the results of LASIK, others have suffered complications. According to the FDA:
• Some patients lose vision. Some patients lose lines of vision on the vision chart that cannot be corrected with glasses, contact lenses, or surgery as a result of treatment.
• Some patients develop debilitating visual symptoms. Some patients develop glare, halos, and/or double vision that can seriously affect nighttime vision. Even with good vision on the vision chart, some patients do not see as well in situations of low contrast, such as at night or in fog, after treatment as compared to before treatment.
• You may be under treated or over treated. Only a certain percent of patients achieve 20/20 vision without glasses or contacts. You may require additional treatment, but additional treatment may not be possible. You may still need glasses or contact lenses after surgery. This may be true even if you only required a very weak prescription before surgery. If you used reading glasses before surgery, you may still need reading glasses after surgery.
• Some patients may develop severe dry eye syndrome. As a result of surgery, your eye may not be able to produce enough tears to keep the eye moist and comfortable. Dry eye not only causes discomfort, but can reduce visual quality due to intermittent blurring and other visual symptoms. This condition may be permanent. Intensive drop therapy and use of plugs or other procedures may be required.
• Results are generally not as good in patients with very large refractive errors of any type. You should discuss your expectations with your doctor and realize that you may still require glasses or contacts after the surgery.
• For some farsighted patients, results may diminish with age. If you are farsighted, the level of improved vision you experience after surgery may decrease with age. This can occur if your manifest refraction (a vision exam with lenses before dilating drops) is very different from your cycloplegic refraction (a vision exam with lenses after dilating drops).
To help ensure that information is available to patients and health care professionals to clearly communicate the benefits and risks of LASIK, the FDA presented its draft guidelines in July and took hundreds of comments during a period that ended in November. It's not clear when the recommendations could be finalized.
"These proposed labeling recommendations, based on extensive consultation with stakeholders and patients, are intended to present information about LASIK in language that is easy to read and understand and include images that convey visual symptoms that could occur following LASIK," Jeff Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, said in a statement. "The draft guidance is designed to support discussions that patients should have with their eye care providers about the benefits and risks of LASIK to help them make informed decisions before proceeding with the surgery."
The FDA's proposed recommendations include: providing general information about the surgical procedure; indications for use; benefits; procedure alternatives; contraindications, warnings and precautions; risks; what to expect before, during and after surgery; clinical study information; and manufacturer contact information.
In addition, the FDA recommends the inclusion of a patient decision checklist that physicians provide prior to the procedure. The proposed checklist includes, among other information, who is a good candidate for LASIK, what to expect after surgery, and a summary of long-term risks of the procedure. It also proposes that the patient and physician sign the checklist to acknowledge it was read and discussed.
Some experts think the FDA recommendations are one-sided and fail to mention the positive outcomes.
"This document mainly emphasizes the dangers and complications of LASIK, with no mention of the advantages, and the tone is negative enough that it will scare patients," Dr. Vance Thompson, incoming vice president of the American Society of Cataract and Refractive Surgery told The New York Times. "All we're asking for is balance."
Others such as Dr. Kira Manusis, M.D., a corneal surgeon at New York Eye and Ear Infirmary of Mount Sinai Health System in New York City, support the guidelines. While the number of patience who experience side effects may just be a small percentage, they can't be overlooked, she told Fox News Digital.
"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," she said. "Risks should be clearly stated in the consent form — and appropriate discussion needs to take place."
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