What is LASIK Eye Surgery?

LASIK stands for Laser-assisted in situ keratomileusis. It is a surgical procedure done to correct a person’s vision, making the person less dependent on corrective glasses or contact lenses. It effects a permanent change on a person’s eye(s), specifically the cornea, which is the clear covering in front of the eyes.

What LASIK does is to correct how the light is bent as it passes through the person’s cornea, focusing it to the retina, to make the image clearer, thus making the person’s vision better. This is an outpatient procedure most often done within 10 to 15 minutes.

How the FDA Regulates LASIK

The US Food and Drug Administration (FDA) regulates LASIK because regulation of medical devices such as lasers used for LASIK is under FDA. Any person or company that intends to sell medical devices must obtain FDA approval by presenting evidence that the medical device or equipment they will be selling are reasonably safe and effective for its intended use. However, the practice of medicine, even with the use of the equipment is no longer under the FDA jurisdiction.

Therefore, the FDA does not have the authority to:

• Set the amount a doctor can charge for LASIK eye surgery
• Regulate a doctor’s practice – the FDA does not tell doctors what to do when running their business or what they can or cannot tell their patients
• Conduct or provide a rating system on any medical device it regulates
• “Insist” that the patient information booklet from the laser manufacturer be provided to the potential patient
• Make recommendations for individual doctors, clinics, or eye centers – the FDA neither maintains nor has access to a list of doctors performing LASIK eye surgery.

Who Should Not Use LASIK?

Not everyone with vision problems are candidates for LASIK surgery. If any of the following applies to you, LASIK surgery may not be for you.

• You are not a risk taker – even if it is an outpatient procedure that probably doesn’t last for more than 20 minutes, there may be possible complications.
• It will jeopardize your career – there are jobs and positions that do not allow refractive procedures such as LASIK. Check with your employer or company policy before proceeding with LASIK.
• Cost is an issue – LASIK surgery comes at a price. Unfortunately, a lot of medical insurance do not cover this procedure so you may be left with financing the surgery yourself.
• Your vision is unstable, that it changes over time (refractive instability). An indication is if you have been required to change your glasses or contact lens prescription within the past year. Those who are most likely to have refractive instability are the following:
  • Those in their early 20s or younger
  • Those who are pregnant or breastfeeding
  • Those who are taking medications that may cause fluctuations in vision
  • Those whose hormones are fluctuating due to disease such as diabetes
• If you have any disease that may compromise your ability to heal wounds, or make you prone to infections, which will affect your healing process after the LASIK surgery. Consider forgoing on the surgery if you have diseases such as HIV, diabetes, rheumatoid arthritis or lupus.
• You are involved in contact sports where it is highly probably that you will get hit in the face or eyes.
• You are a minor. Minors or those under 18 are too young to have LASIK surgery because their vision is still prone to change.

LASIK Precautions

Before LASIK surgery, candidates must be screened for the following to ensure that risks and complications are minimized:

• Thin corneas
• Large pupils
• Dry eyes
• Blepharitis (inflammation of the eyelids with crusting of the eyelashes)
• Previous refractive surgery, such as LASIK, RK, or PRK

What Should I Tell My Healthcare Professional?

It is very important to let your healthcare professional know if you have a history in any of the following before proceeding with the LASIK surgery:

• Glaucoma, glaucoma suspect, or ocular hypertension
• Keratoconus
• Herpes simplex or herpes zoster (shingles) involving the eye area
• Eye injuries or previous eye surgeries
• Eye diseases, such as uveits/iritis (inflammations of the eye)

LASIK Health Risks

There are numerous benefits that can happen because of a clearer vision as a result of the LASIK surgery. However, despite many satisfied patients, there are still possible risks to the procedure. Consider the following risks to help you decide whether to go through LASIK surgery based on the pros and cons.

• Some patients develop debilitating visual symptoms such as glare, haloes, and/or double vision that can seriously affect night time vision
• Some patients lose lines of vision.
• For some farsighted patients, results may diminish with age.
• You may be under-treated or over-treated – you may still need glasses or contact lenses after surgery
• Results are generally not as good in patients with very large refractive errors of any type.
• Some patients may develop severe dry eye syndrome – when the eye is not able to produce enough tears to keep the eye moist, it may cause discomfort and reduce visual quality.
• Long-term data is not available, since LASIK is a relatively new technology – the long-term safety and effectiveness of LASIK surgery is still unknown.

LASIK – Getting Legal Help

Given that there are possible risks to certain equipment used in medical procedures, the manufacturer of such equipment have the duty to make products that are as reasonably safe as possible. It is also the duty of the manufacturer to inform the public and medical community of any known risks related to the use of the product. If the manufacturer fails to warn the public and the medical community of such risks, they can be held liable under product liability theory for injuries caused by inadequate warning or unreasonably dangerous nature of their product.

If you or your loved one have been injured or have been adversely affected after going through LASIK surgery let your doctor know as soon as possible. You may also want to consider consulting with an experienced personal injury attorney to know more about your rights and discuss possible steps to take in order to protect your rights and claim remedy for injuries you suffered because of LASIK surgery.