LASIK Eye Surgery: Legal Information

LASIK (Laser-Assisted In Situ Keratomileusis) is a surgical procedure that can reduce a person’s dependency on glasses or contact lenses. It is ideal for patients with astigmatism. The procedure permanently changes the shape of the cornea, which is the delicate clear covering on the front of the eye.

In people with normal vision, the cornea bends. This allows it to refract light back onto your retina. But this doesn’t happen in people who have nearsightedness or farsightedness. The same is true for people with astigmatism.

Thousands of Americans undergo LASIK eye surgery every year. For most people, the risks are minimal. People who have LASIK are usually happy with the results. The Mayo Clinic says over 80% of LASIK patients experience improved vision. They no longer need glasses or contact lenses.

However, results aren’t always positive. Some patients have complications with their procedure or aren’t satisfied with the outcome.

This article shares the side effects and issues some people experience after LASIK surgery. It also discusses regulation and guidance for the procedure under the U.S. Food and Drug Administration (FDA).

If you have been harmed after a LASIK procedure, you may have a personal injury or medical malpractice claim. It depends on the facts of your situation. A personal injury lawyer near you can evaluate your LASIK injury claim and offer personalized legal advice.

Is LASIK Safe?

Surgeons perform LASIK eye surgery on people who have nearsightedness (myopia). LASIK is an outpatient surgical procedure that usually takes 10 to 15 minutes for each eye.

LASIK isn’t appropriate for everyone, but the FDA has approved LASIK as a safe and effective procedure. It’s essential to have a complete evaluation before undergoing LASIK. People who aren’t good candidates but undergo the surgery anyway may experience poor results.

What Are the Risks of LASIK Eye Surgery?

LASIK eye surgery is a vision correction procedure your eye doctor performs to improve your vision. It helps correct a host of vision problems. Some of these include:

• Myopia (nearsightedness)
• Hyperopia (farsightedness)
• Astigmatism

In most cases, LASIK surgery successfully improves a patient’s vision. Once the surgeon corrects the shape of your cornea, you should be able to see much better than before. At a minimum, patients can expect 20/40 vision.

Unfortunately, as with any surgery, there are risks of LASIK. Some of the adverse visual symptoms of refractive surgery include:

• Extremely dry eyes
• Glare or halos
• Trouble seeing in the dark
• Regression to pre-surgery vision
• Double vision
• Vision loss
• Undercorrection (meaning you may still need glasses or contact lenses after surgery)
• Eye pain
• Overcorrection
• Starbursts
• Corneal ectasia
• Astigmatism

LASIK results are generally not as good in patients with substantial refractive errors. For some farsighted patients, results may diminish with age.

If you experience any of these side effects, contact your healthcare provider. Sometimes, you may need additional surgeries to improve your eye health. It depends on the nature of your injury.

LASIK Precautions

There are specific precautions you must take to have a successful surgery. Your laser eye surgery provider 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

Your ophthalmologist will conduct other tests during your LASIK consultation. For instance, they’ll do a preliminary eye exam to determine if you have farsightedness or have issues with distance vision.

Your LASIK surgeon will also need to know if you use reading glasses or other devices while reading, driving, or performing daily tasks. If you use eye drops regularly, let your surgeon know.

Does LASIK Hurt?

LASIK generally doesn’t hurt. You’ll receive anesthetic drops to numb your eye, making the procedure painless. According to the Flaum Eye Institute’s LASIK FAQ, some people feel pressure around the eye during surgery.

After your procedure, you may feel like something is in your eye for a few hours. You can ask your doctor for a pain reliever if needed. By the next day, you should feel fine. Most people rest and take their preferred non-prescription pain reliever.

Certain Patients Should Not Use LASIK

As with any other procedure, such as cataract surgery, certain patients are not good candidates for LASIK eye surgery.

According to the FDA, if you meet the following conditions, you should reconsider vision correction procedures, including LASIK. These conditions include the following:

• You don’t want to take a risk: Some eye surgery risks are unavoidable. There’s no long-term data available for current LASIK procedures.
• It could harm your career: Some jobs prohibit specific refractive procedures. Be sure to check with your employer or an expert in your field before undergoing any medical procedures. You can also consult with a local eye center to see what they say about the impact surgery will have on your career.
• The cost is a concern: Although prices have decreased, they are still significant. Most insurance carriers won’t pay for LASIK surgery. Of course, most eye surgeons offer financing options. You’ll have to decide after meeting with an eye care specialist.
• 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 drugs that may affect wound healing: These conditions include autoimmune diseases, immunodeficiency states, and diabetes.
• You play contact sports: If you participate in sports where blows to the face and eyes are normal, LASIK may not be appropriate.
• You are a minor: Currently, the FDA has not approved LASIK lasers for people under 18.
• You have keratoconus, corneal ectasia, or constant dry eyes.

FDA Regulation and LASIK

In the U.S., the FDA regulates the sale of medical devices, including the excimer lasers used for LASIK. Companies must receive FDA approval before legally selling a medical device in the U.S.

To gain this approval, an applicant must present evidence that the device is reasonably safe and effective for a particular use. Doctors can decide to use a medical device for other uses if it’s in the patient’s best interest. But the FDA doesn’t regulate this use or the doctor’s practice of medicine.

So, the FDA doesn’t have the authority to:

• Regulate an eye doctor’s practice
• Tell doctors what to do or what they can tell their LASIK patients
• Set the amount a doctor can charge for LASIK eye surgery
• Insist doctors give a potential client the patient information booklet from the laser manufacturer
• Make recommendations for eye doctors or clinics
• Maintain or have access to a list of doctors who perform LASIK eye surgery
• Conduct or provide a rating system on medical devices

It may seem like the FDA doesn’t do enough to protect patients. But their power only extends so far. The FDA does perform follow-up evaluations to ensure the safety of medical devices.

FDA Guidance on LASIK Surgical Procedures

The FDA has issued numerous reports on LASIK eye surgery. For example, in March 2009, the FDA drafted new surgical standards for LASIK.

The FDA also ordered all LASIK surgical centers to report any adverse events at their facility. This included any issues with defective LASIK devices. The agency also welcomed public comments about LASIK surgery.

People who have undergone the procedure can go online and report any issues they have with eye surgery.

The FDA found that many facilities were not reporting issues with LASIK surgery. It issued letters to these surgical centers demanding they fix these outstanding issues and submit their reports on time.

More recently, in July 2022, the FDA issued a draft guidance on the increasing risks of LASIK. The FDA posted this draft on the federal register. This allowed people to post public comments about the proposed regulations on doctor’s warnings.

Once the FDA enacts this new regulation, eye surgeons must discuss specific risks with potential candidates. They must also complete a checklist and have the patient sign that checklist.

The issues the surgeon must specifically address include:

• Severe dry eyes
• Night vision problems
• Visual disturbances

According to the New York Times, the FDA is cracking down on LASIK surgical centers.

Where To Report a Bad Experience With an Eye Doctor

Most people who have LASIK surgery report a positive experience. If your experience is unpleasant, you can file a voluntary report with the U.S. Food & Drug Administration’s MedWatch program at 1-800-FDA-1088. You can also file a complaint online.

You can also contact the state optometry or medical licensing board to file a complaint. Your state may also have a consumer complaint organization, such as the Better Business Bureau (BBB) or a state consumer protection agency, where you can file a complaint.

Is There an Alternative to LASIK?

According to leaders in the ophthalmology field, the number of patients opting for LASIK is going down. Up until 2021, the number of patients undergoing LASIK surgery increased. 2023 was the first year where the number of procedures decreased. But recent reports show people choose less risky procedures to correct their vision.

One of the more popular options is photo-refractive keratectomy (PRK). This procedure doesn’t involve any cutting. This means there is less trauma to the eye and a lower chance of flap issues and vision loss.

PRK also involves a lower risk of dry eyes, night vision problems, and other complications.

What To Do if Your Laser Eye Surgery Causes Injuries

Whenever you have a surgical procedure, there are potential risks. There is also a chance that you won’t be happy with the results. Your surgeon can never guarantee positive results when you undergo an elective procedure.

The good news is that LASIK surgery has a high satisfaction rate. More than 80% of LASIK patients are happy with the results. Also, very few people suffer an injury during the LASIK procedure.

You may encounter LASIK complications. Some patients need corrective surgery a year after their initial LASIK procedure. For example, the surgeon may cut off too much eye tissue. Or they may not cut off enough.

If this is the case with you, or if you suffer other injuries, you may have a legal claim.

How To Find an Attorney To Help With Your LASIK Claim

If you have LASIK surgery and suffer a personal injury, you have options. First, you must make an appointment with an experienced eye doctor. Then, contact a lawyer and schedule your free case evaluation.

You may have a claim for medical malpractice. If the surgeon didn’t perform the procedure correctly, you may be able to sue their insurance carrier. If your injuries are due to a defect in the surgical equipment, you may have a valid product liability claim. Your attorney will help determine the best route to take.

You can recover significant compensation depending on the nature and extent of your injuries. FindLaw’s directory of product liability attorneys and medical malpractice attorneys can connect you with qualified legal help near you. Select your state or city to review contact and ratings information for local experts. Then, reach out to a trusted expert—they may be your strongest advocate throughout the legal process.