Lasik Risks Must be Disclosed in Advertisements Warns FDA

The FDA has notified healthcare providers that any advertisements for laser eye surgery procedures must adequately disclose the possible risks of Lasik, as many patients have reported suffering blurry vision, double vision and other eye problems.

The warning comes in the wake of FDA hearings held in April 2008 that addressed many of the Lasik risks and complaints of former patients who experienced problems after Lasik eye surgery.

LASIK (laser-assisted in-situ keratomileusis) is a form of corrective eye surgery that uses a laser to improve a patient’s vision and reduce their need to wear glasses or contact lenses.

During the eye surgery, a surgical instrument known as a microkeratome is used to cut through the top layers of the cornea to create a flap. A laser beam is then used to reshape the cornea for vision correction and the corneal flap is replaced.

“The FDA has received complaints that eye care professionals’ advertisements for LASIK procedures and FDA-approved lasers used for the LASIK procedures failed to inform consumers of the indications, limitations, and risks associated with LASIK procedures and the approved lasers used for the LASIK procedures,” the FDA letter states.

The FDA has set up a special section of its website for consumers about potential problems with LASIK and other information to help consumers make a decision about whether the procedure is right for them.

According to the information posted by the FDA, the following Lasik risks should be considered before undergoing corrective eye surgery:

• Vision loss that cannot be corrected with glasses, contact lenses or additional surgery
• Debilitating visual symptoms such as glare, halo and/or double vision that can seriously effect vision at night or in fog
• Undertreatment or overtreatment may result in a failure to achieve 20/20 vision, and additional treatment may not be possible. Therefore, patients may still require glasses or contact lenses after srugery.
• Dry eye syndrome may occur, which could prevent the eye from developing enough tears, causing discomfort and reduced visual quality.
• Results are generally not as good in patients with very large refractive errors.
• Results may diminish with age for some farsighted patients.
• Long-term data is not available, as the first laser was approved for LASIK eye surgery in 1998.

The known risks of Lasik surgery have, so far, not been included in most advertisement, critics argue. Additionally, a 2008 American Journal of Ophthalmology report found that additional surgeries were needed for 28% of the eyes treated with LASIK less than 10 years after the initial surgery, due to undercorrection, overcorrection, or regression.

Lasik surgery malpractice lawsuits have been brought against eye surgeons for failing to follow the appropriate standard of care, most commonly for problems that develop after a doctor fails to properly screen a patient out as a potential candidate for the eye surgery.