The Food and Drug Administration has declared its plans to begin a study of the negative side effects following Lasik eye surgery, which include dry eyes, blurred/double vision, and halos around objects at night. According to a recent report, the FDA will coordinate with the Department of Defense and the National Eye Institute to establish the percentage of patients who have been negatively affected by the eye-correcting procedure.
Although it is encouraging that such action is finally being initiated, a clinical trial tracking of patients who undergo the surgery will not conclude until 2012. To start things off, an online questionnaire will help patients gauge their quality of life after Lasik surgery. The head of the FDA’s medical device division stated, “This study will enhance our understanding of the risks of Lasik and could lead to a reduction in patients who experience adverse effects.”
Considering that approximately 6 million Americans have had Lasik surgery, an extremely sensitive procedure that everlastingly reshapes the cornea (a clear layer covering the eye), it is of the utmost importance that the FDA administers this study. Although 95% of Lasik patients are apparently satisfied with the results of their surgery, last summer the FDA received 140 reports of Lasik-related problems of eye damage between 1998 and 2006.
The report also mentions that FDA warning letters were issued to 17 Lasik surgery centers regarding inadequate adverse event reporting procedures. Facilities like Lasik centers are required to follow federal guidelines of reporting patient complaints; however, some facilities fail to adhere to such regulations. The lasers in question are made by Advanced Medical Optics Inc., Bausch and Lomb, and Alcon Inc and additional inspections of Lasik centers are said to take place in the upcoming months.
If you or a loved one has undergone Lasik eye surgery and have experienced adverse reactions to the procedure, you should seek medical attention as soon as possible to address the issue. You may also want to contact a knowledgeable and skilled personal injury attorney that has experience handling medical malpractice and product liability cases. Call Anapol Weiss today at 866-735-2792 for a free consultation of your Lasik eye surgery side effect case.