LASIK Eye Surgery
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of legal writers and editors.
LASIK (Laser-Assisted In Situ Keratomileusis) is a surgical procedure that can reduce a person's dependency on glasses or contact lenses. The procedure permanently changes the shape of the cornea, which is the delicate clear covering on the front of the eye. To have clear vision, the eye's cornea and lens must bend (refract) light rays properly, so that images are focused on the retina. If light rays aren’t clearly focused, vision can be blurred.
LASIK eye surgery is performed most often on people who have nearsightedness (myopia). LASIK is an outpatient surgical procedure that normally takes 10 to 15 minutes for each eye.
For more information, see the FindLaw LASIK Eye Surgery FAQs.
How the FDA Regulates LASIK
In the U.S., the Food and Drug Administration (FDA) regulates the sale of medical devices, including lasers used for LASIK. A person or company must seek FDA approval before legally selling a medical device in the U.S. To gain approval, the applicant must present evidence that the device is reasonably safe and effective for a particular use. After, a doctor may decide to use an approved medical device for other uses if in the best interest of the patient. However, the FDA doesn’t regulate such use or the practice of medicine.
Therefore, the FDA doesn’t have the authority to:
- Regulate an eye doctor's practice. The FDA doesn’t tell doctors what to do in running their business or what they can or can’t tell their patients.
- Set the amount a doctor can charge for LASIK eye surgery.
- "Insist" that the patient information booklet from the laser manufacturer be provided to the potential patient.
- Make recommendations for eye doctors or clinics. The FDA doesn’t maintain or have access to a list of doctors who perform LASIK eye surgery.
- Conduct or provide a rating system on any medical device the FDA regulates.
Who Should Not Use LASIK?
You are probably not a good candidate for LASIK eye surgery if:
- You don’t want to take a risk. Some risks of eye surgery are unavoidable and there's no long-term data available for current LASIK procedures.
- It could harm your career. Some jobs prohibit certain refractive procedures, so be sure to check with your employer or an expert in your field before undergoing any medical procedures.
- The cost is a concern. Although costs have decreased was LASIK becomes more commonplace, they are still significant and most medical insurance won’t pay for this surgery.
- Your contact lens or glasses prescription changed in the past year. Patients who are more likely to have this refractive instability include patients who:
- Are in their early 20s or younger
- Have fluctuating hormones due to diabetes or another condition
- Are pregnant or breastfeeding
- Take medications that may cause fluctuations in vision.
- You have a disease or are on medications that may affect wound healing. These conditions include: autoimmune diseases (e.g., lupus, rheumatoid arthritis), immunodeficiency states (e.g., HIV), and diabetes, as well as some medications (e.g., retinoic acid and steroid).
- You actively participate in contact sports. If you participate in sports where blows to the face and eyes are a normal occurrence (e.g., boxing, wrestling, martial arts), LASIK may not be appropriate.
- You are a minor. Currently, no LASIK lasers are approved for people under the age of 18.
Your healthcare professional should screen for the following conditions or indicators of risk before undergoing LASIK eye surgery:
- Blepharitis (inflammation of the eyelids with crusting of the eyelashes)
- Large pupils
- Thin corneas
- Previous refractive surgery, such as LASIK, RK, or PRK
- Dry eyes
What Should I Tell My Healthcare Professional?
Before undergoing LASIK eye surgery, tell your healthcare professional if you have a history of any of the following:
- Herpes simplex or zoster (shingles) in or near the eyes
- Glaucoma, glaucoma suspect, or ocular hypertension
- Eye diseases, such as uveits/iritis (inflammations of the eye)
- Eye injuries or previous eye surgeries
- Keratoconus (a thinning disorder of the cornea that causes visual distortion)
LASIK Health Risks
While most patients are pleased with the results of LASIK or other refractive surgery, there are risks involved. The following are some of the risks that should be carefully weighed against the benefits of undergoing LASIK:
- Some patients lose lines of vision.
- Some patients develop debilitating visual symptoms such as glare, haloes, and/or double vision that can seriously affect nighttime vision.
- You may be under-treated or over-treated, meaning you may still need glasses or contact lenses after surgery.
- Some patients may develop severe dry eye syndrome, when the eye isn’t able to produce enough tears to keep the eye moist, it may cause discomfort and reduce visual quality.
- Results are generally not as good in patients with very large refractive errors of any type.
- For some farsighted patients, results may diminish with age.
- Long-term data isn’t available, since LASIK is a relatively new technology, the long-term safety and effectiveness of LASIK surgery is still unknown.
Getting Legal Help
Even with the anticipated risks of eye surgery, when patients are injured because of inadequate warnings or unreasonably dangerous products or the bad actions of the eye doctor, they can seek compensation under either product liability law or medical malpractice. To learn more about an attorney's role in these types of cases, see the Get Legal Help with a Defective Product Injury and Get Legal Help with a Medical Malpractice Issue articles.
If you or a loved one have experienced any dangerous health effects or unusual medical conditions after undergoing LASIK or other refractive surgery, contact your doctor or other healthcare professional. Then, contact an experienced attorney to discuss your options and protect your right to a legal remedy for any injuries caused by your eye surgery.