The FDA issued warning letters to several laser eye surgery providers this week, indicating that the companies had put out misleading advertising.
The FDA announced the LASIK eye surgery warnings on December 18, after reviewing their advertising and promotional materials, which the agency determined failed to adequately warn consumers about the risks of laser eye surgery.
LASIK (Laser-Assisted In Situ Keratomieusis) eye surgery is a form of vision correction using refractive lasers to reshape the cornea. It is used to address nearsightedness, farsightedness and astigmatism.
The FDA sent warning letters to five providers, telling them that their advertising was misleading for failing to give proper warnings. The recipients of the letters included:
- 20/20 Institute Indianapolis LASIK, of Indianapolis, Indiana
- Scott Hyver Visioncare Inc., of Daly City, California
- Rand Eye Institute, of Deerfield Beach, Florida
- Eye Center of Texas, of Bellaire, Texas
- Woolfson Eye Institute, of Atlanta, Georgia
If the providers fail to address their advertising problems, the FDA warned it could take further action, including an injunction preventing them from doing business, seizure of equipment and inventory, or they could face civil monetary fines.
While corrective laser eye surgery procedures have been heavily marketed in recent years, they do come with potential risks. Some of the common side effects of laser eye surgery may include severe dry eye syndrome, visual issues like halos, glare, starbursts and double vision, loss of vision, and the continued need for glasses or contact lenses after surgery.
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.
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 where the doctor failed to properly screen patients out as a potential candidate for the eye surgery.
According to 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.