FDA Warns Over Lasik False Marketing Claims

According to a recent warning issued by federal regulators, some LASIK eye care surgeons may not be telling their patients about the full risks associated with the procedure and the FDA is threatening those that fail to advertise properly with fines, injunctions and product seizures. 

The FDA issued a Letter to Eye Care Professionals on September 23, warning against the use of dishonest advertising practices that omit important risk information.

This is the second letter the FDA has sent to the Laser-Assisted In Situ Keratomileusis (LASIK) corrective eye surgery community. The first LASIK warning letter was issued on May 22, 2009.

Despite the 2009 warning, the FDA reports that it is still receiving information on misleading advertising practices and improper promotion by eye care professionals that downplay the risks of laser eye surgery. Eye care centers have 90 days to correct misleading ads or they could face enforcement action by the FDA. The agency did not detail what the misleading advertisements stated.

LASIK is a form of 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.

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.

Reports of LASIK problems can involve double vision, halos around objects at night and dry eyes. In more severe cases, complications can have a severe impact on an individual’s quality of life.

Although rare, a number of patients have filed Lasik surgery malpractice lawsuits against eye surgeons over complications that were allegedly caused by a failure to follow the appropriate standard of medical care, most commonly involving problems that occur after a doctor fails to properly screen patients out as a potential candidate for the eye surgery.

The FDA has set up a special section of its website for consumers to outline the potential problems with LASIK and provide 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.