FDA LASIK Risks

The FS and iFS Laser systems are ophthalmic surgical lasers indicated for use in patients undergoing surgery or treatment requiring the initial lamellar resection of the cornea. Contraindications may include corneal edema, glaucoma, and keratoconus. Risks and complications may include corneal pain, flap tearing, and epithelial ingrowth. Consult with your eye care professional for a complete listing of contraindications and risks. US Federal law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care practitioner.

Most patients are very pleased with the results of their refractive surgery. However, like any other medical procedure, there are risks involved. That’s why it is important for you to understand the limitations and possible complications of refractive surgery. Before undergoing a refractive procedure, you should carefully weigh the risks and benefits based on your own personal value system, and try to avoid being influenced by friends that have had the procedure or doctors encouraging you to do so.

  • 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).
  • Long-term data are 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.

FDA RISKS:

As with any surgical procedure there are risks associated with CustomVue TM treatments. It is important to discuss these risks with your doctor before you make the decision to have the surgery. If the results of the surgery are not satisfactory, you may need to have additional laser treatment in the same eye. Your doctor may perform CustomVue LASIK for both eyes. However, sometimes it is better to have this procedure done on only one eye. Talk with your doctor about whether it would be better to treat one or both of your eyes.

Some risks are related to the creation of the corneal flap. Corneal flap complications include but are not limited to: cutting an incomplete, irregular flap or free flap; misalignment of the flap; and perforation of the cornea. Corneal flap complications range in severity from those that simply require the treatment to be postponed for several months, to those which create corneal irregularities resulting in permanently blurred vision.

You may need reading glasses after laser surgery even if you did not wear them before. Your vision may not be perfect, and you may need to wear glasses or contact lenses for some activities even after laser vision correction.

CONTRAINDICATIONS:

If you have any of the following situations or conditions you should not have LASIK because the risk is greater than the benefit:

  • You are pregnant or nursing, because these conditions may cause temporary and unpredictable changes in your cornea and a LASIK treatment may improperly change the shape of your cornea.
  • You have collagen vascular disease (e.g., rheumatoid arthritis), autoimmune disease (e.g., lupus), or immunodeficiency disease (e.g., AIDS), because these conditions affect the body’s ability to heal.
  • You show signs of keratoconus or any other condition that causes a thinning of your cornea. This condition can lead to serious corneal problems during and after LASIK surgery. It may result in need for additional surgery and may result in poor vision after LASIK.
  • You are taking medications with ocular side effects, e.g., isotretinoin (Accutane®*) for acne treatment or amiodarone hydrochloride (Cordarone®t)for normalizing heart rhythm, because they may affect the accuracy of the LASIK treatment or the way your cornea heals after LASIK. This may result in poor vision after LASIK.
  • Your corneas are thin. If your corneas are too thin to allow your doctor to cut a proper flap in the LASIK procedure, you can’t have LASIK because it is necessary to have a flap.

For more information, please visit http://www.fda.gov/medicaldevices/productsandmedicalprocedures/surgeryandlifesupport/lasik/ucm061354.htm