LASIK: What the FDA Says and Questions to Ask
A plain summary of the FDA's LASIK pages: who may not be a good candidate, the risks it lists, its checklist, and questions for a surgeon.
LASIK is surgery that reshapes the cornea, the clear front surface of the eye, to reduce how much a person relies on glasses or contact lenses. Whether it is right for anyone is a decision for that person and an eye surgeon. This guide does not make that call. It summarizes what the U.S. Food and Drug Administration (FDA) says about LASIK on its LASIK information pages, and lists questions you can take to a consultation.
What LASIK is
The FDA describes LASIK (laser-assisted in situ keratomileusis) as a procedure that permanently changes the shape of the cornea using an excimer laser. The surgeon first cuts a hinged flap in the cornea, either with a mechanical blade device called a microkeratome or with a laser. The flap is folded back, the laser removes a small amount of tissue underneath, and the flap is laid back in place.
What the FDA does and does not do
The FDA approves the lasers used for LASIK, which must be shown to be reasonably safe and effective for a particular use before they can be sold in the United States. According to the FDA's page on its role in LASIK, it does not regulate how doctors practice, does not set what they charge, cannot require that you be given the laser maker's patient booklet, and does not recommend or rate individual doctors or clinics. Its LASIK FAQ adds that it keeps no list of LASIK surgeons and does not compare lasers against each other.
When the FDA says LASIK may not be a good fit
The FDA's page "When is LASIK not for me?" says a person is probably not a good candidate for refractive surgery if:
- They are not comfortable with risk. Some complications cannot be avoided in a share of patients, and long-term data for current procedures are not available.
- It could affect their career. Some employers, professional bodies and military services restrict certain refractive procedures.
- Cost is a concern. The FDA notes that most medical insurance will not pay for refractive surgery.
- Their glasses or contact lens prescription changed in the past year.
- They have a disease or take medications that may affect healing.
- They play contact sports in which blows to the face are normal.
- They are under 18. The FDA says no lasers are approved for LASIK in people under 18.
The same page lists conditions to discuss with a doctor because safety and effectiveness have not been established, including a history of herpes infection around the eye, glaucoma or high eye pressure, eye inflammation, earlier eye injuries or surgery, and keratoconus. It also says doctors should screen for eyelid inflammation (blepharitis), large pupils in dim light, thin corneas, previous refractive surgery and dry eye.
The risks the FDA describes
On its page about risks and finding the right doctor, the FDA says that most patients are very pleased with their results, and also lists risks, including:
- Some patients lose lines of vision on the eye chart that cannot be corrected with glasses, contact lenses or more surgery.
- Some develop glare, halos or double vision that can seriously affect night vision.
- The eye may be undercorrected or overcorrected. More surgery may or may not be possible, and some people still need glasses or contacts, including reading glasses.
- Severe dry eye can develop and may be permanent.
- Results are generally not as good for very large prescriptions, and for some farsighted patients the improvement may fade with age.
- Long-term safety and effectiveness are not known; the first laser was approved for LASIK in 1998.
The FDA also describes extra considerations for monovision, where one eye is corrected for distance and the other for near vision, and for having both eyes treated on the same day, which it says carries more risk than separate surgeries.
The FDA's checklist
The FDA publishes a LASIK surgery checklist organized around four areas: what may make you a poor candidate, the risks and limits of the procedure, how to find the right doctor, and what to expect before, during and after surgery. Reading it before a consultation can help you write down your own questions. The FDA's page on what to expect also says contact lens wearers are advised to stop wearing them for a period before the baseline exam, because lenses can change the shape of the cornea and affect the measurements; ask your doctor what applies to you.
Questions to ask a surgeon
These questions draw on the FDA's checklist and risk pages:
- How many LASIK procedures have you done with the laser you would use for me?
- Is that laser FDA approved for my type and degree of prescription? (The FDA FAQ explains how to look up approved lasers.)
- May I read the laser manufacturer's patient information booklet, and how do your results compare with the studies in it?
- What makes me a good or poor candidate, based on my corneal thickness, pupil size, tear film and prescription history?
- What results are realistic for me, and how likely am I to need glasses or a second procedure?
- Do you treat both eyes on the same day, and why?
- Who provides my care before and after surgery, and how do I reach someone if problems come up?
- Can I take the informed consent form home to read before I decide?
- What is the total cost, including follow-up visits and any enhancement?
Advertising and pressure
The FDA suggests comparing more than one doctor and eye center, not deciding on cost alone, and being wary of ads that promise "20/20 or your money back" or package deals, since there are no guarantees in medicine. It also says you should not feel pressured by your doctor, family or friends to decide. You can take time to think, review the material you are given and get a second opinion.
Checking the surgeon and reporting problems
Ask who will perform the surgery. You can check a surgeon's state medical license and American Board of Ophthalmology certification using the steps in our guide to optometrists, ophthalmologists and opticians. The FDA's checklist notes that care before and after surgery may be provided by a doctor other than the surgeon, so ask who will see you at each stage and check that person's license too.
If you have a problem after LASIK, the FDA asks patients to report it through MedWatch, including the name of the laser and its manufacturer. Its FAQ also suggests contacting your state medical licensing board. If you have sudden vision loss, severe pain or an eye injury, seek care right away and call 911 in an emergency.
Our listings are organizations whose self-reported specialty in the federal NPPES registry is optometry or ophthalmology. A listing does not show whether a practice performs LASIK, what it charges or how it rates; it is not an endorsement. This guide is general information, not medical advice.
General information only, current as of the date above. The information on Eye Doctor Index is not medical advice and does not replace a doctor, nurse, discharge planner or other qualified professional. Do not use it to make decisions about diagnosis or treatment. If you have a medical emergency, call 911. Rules and programs change; check the official sources linked in this guide.