On Friday April 25, 2008 The U.S. Food and Drug Administration's Ophthalmic Devices Panel convened to discuss post-LASIK quality-of-life issues. To date nearly 12 million people have had LASIK eye surgery in the United States. In 2007, the LASIK study task force was formed to evaluate the satisfaction of patients worldwide who have had LASIK. The task force consists of the FDA, the American Society of Cataract and Refractive Surgery, the American Academy of Ophthalmology, and the U.S. National Eye Institute. The task force found a 95 percent satisfaction rate among LASIK patients worldwide. However, of the 8 million people who have had LASIK in the United States, the FDA received letters of complaint from 140 patients.  Patients complained of numerous problems to include eye pain and irritation, dry eyes, and blurred or double vision. It should be noted that the FDA reaffirmed that LASIK is both a safe and effective procedure and with modern technologies LASIK is providing superior safety and better visual outoutcomes than ever before. However, after hearing patient complaints and comments by panel physicians the panel recommended that the FDA increase patient awareness about risks involved in LASIK eye surgery and advised the FDA to conduct a study to determine the quality of life issues affecting patients after having had LASIK.

LASIK Facts:  

• 12.4 million LASIK procedures have been performed in the U.S. since its FDA approval in the mid -90's.
•  LASIK is one of the most common elective procedures performed in the world today by volume.        
• But LASIK is not for everyone. Approximately 20-25 percent of individuals seeking LASIK are determined to be    ineligible candidates during pre-operative screenings.        
• LASIK is a two-step procedure. First, a thin, circular flap is made in the cornea using a microkeratome or femtosecond laser. The surgeon then folds the flap out of the way. In the second flap, the corneal tissue underneath is reshaped using an excimer laser, which employs a cool ultraviolet light beam. When the cornea is reshaped in the right way, it works better to focus light into the eye and onto the retina, providing clearer vision than before. The flap is then laid back in place, covering the area where the corneal tissue was removed. The procedure is quick and virtually painless. LASIK can be used for nearsightedness (myopia), farsightedness (hyperopia) and astigmatism. 
•  Patients are reminded that no surgical procedure is ever risk-free. 
• Risks and complications may include dry eye, glare/halos and double vision, which may resolve over time or in some cases can be managed with enhancements or subsequent therapy.        
• Serious complications are well below one percent according to ophthalmology trade journals.
• Technology has advanced substantially since the first excimer laser was FDA approved for use in LASIK. Today's "modern LASIK" combines the use of 3-D mapping with wave-front guided or optimized excimer lasers and mechanical or laser flap technology to provide superior safety and better visual outcomes.
• In September 2007, NASA approved the use of modern LASIK for astronauts.
• LASIK also has been cleared for U.S. Military personnel, including Air Force pilots. In fact, the Department of Defense reports that LASIK has been performed a quarter of a million procedures on 112,500 military personnel.
• LASIK is one of the most-studied medical procedures. Worldwide, 95.4 percent of patients report they are satisfied with the procedure. Collectively, 7,830 patients (representing 16,502 eyes) participated in clinical trials from 1993-2005.