FDA to Study Complaints from Lasik Patients

Ten years after Lasik eye surgery first made an impact in the market, patients suffering from the wide range of side effects of the procedure have finally begun to complain about the procedure to federal health officials.

FDA officials are now initiating a public hearing Friday as part of its efforts to find out whether the patients receive adequate and appropriate warnings about the risks associated with the procedure before opting to go through with it. In collaboration with eye surgeons, the agency is attempting a major study on patients who have undergone the procedure.

Through this study, the agency hopes to be able to work with hundreds of patients who have undergone the Lasik eye surgery procedure to know more about who suffers from the side effects and what the effects actually are in different individuals.

In a statement on Thursday, Dr. Daniel Schultz, the medical device chief of the FDA, said, “Clearly there is a group who are not satisfied and do not get the kind of results they expect. The study should "help us predict who those patients might be before they have the procedure.”

There is no doubting the fact that Lasik eye surgery works wonders for a majority of the patients who opt for it. There have been instances of patients having better than 20/20 vision after they have undergone the procedure.

Though Lasik eye surgery is costly, almost $2,000 per procedure, so far 7.6 million Americans have undergone it. The high number of patients despite the cost is mainly because of the high success rate, almost 95 percent.

However, there is a small minority that is hit by the side effects, some of which can be drastic, including reduced night vision, reduced vision, and also dryness and pain in the eyes.

Doctors, however, advise one in four patients against undertaking the procedure, mainly because of structural problems with their cornea itself or some other associated physical condition that could maximize the risk of side effects after the procedure.

According to Medical University of South Carolina’s Dr. Kerry Solomon, leader of a review of the degree of safety associated with Lasik for the American Society of Cataract and Refractive Surgery the number of patients suffering from poor eyesight as a result of severe post-Lasik complications is less than one percent.

While officials at the Food and Drug Administration put the number of patients who have been hit by the side effects at a miniscule 5 percent, there has been no official record of the magnitude of the risks associated with the procedure, the actual number of patients hit by the side-effects, the impact of the effects on a patient’s life, and other related issues.

This is where the FDA’s new study will be of help. It will be able to provide details on the issues mentioned above.