Stronger Warnings For Lasik Surgery From FDA

Lasik Surgery (laser-assisted in situ keratomileusis) is the most advanced eye surgery. According to Golfer Tiger Woods "It is a life changing". NASA is now allowing astronauts to undergo this procedure, and in the U.S. military, nearly 112,500 personnel, have undergone this surgery, including pilots.

But FDA (U.S. Food and Drug Administration's) Ophthalmic Devices Panel convened Friday to discuss post-LASIK quality-of-life issues. At the end of the day FDA warn more clearly about the risk and post complications of the Lasik Surgery.

On hearing this problem Dr Christopher Starr says, "This is ground-breaking news. It's the first time anything like this has happened around refractory, or LASIK, eye surgery. I think this surgery is the best , because I know that the surgery, when done on the right patients, is a great, great surgery with phenomenally good outcomes." According to the Lasik Surgery task force, formed in 2007, 95.4% of patients were satisfied. This task force was conducted by FDA, The American Academy of Ophthalmology, and the U.S. National Eye Institute.

But FDA is revealing latest news, that among 7.6 million people who have undergone this procedure in the United States in the mid 1990's, 140 have written complaint to the FDA. Now FDA is following up the complaints, and the Friday's hearing was a part of the large review to see if new warnings about the Lasik Surgery are needed to alert the consumers to the possibility of the eye pain, dry eyes, blurred or double vision, and other problems.

Some of the affected patients were present on Friday, and they complaint that their vision is not cured rather they have poor night vision, some have glare or halos, some complained of dry eye "The FDA has called it as quality-of-life-issue". said Dr. Robert Cykiert, associate professor of ophthalmology at New York University Langone Medical Center.

"Too many Americans have been harmed by this procedure, and it's about time this message was heard," said David Shell of Washington, D.C., who had the surgery in 1998 and said he has "not experienced a moment of crisp, good quality vision since".

LASIK surgery involves cutting a small flap in the eye's cornea using a laser. With the flap held out of the way, the surgeon can then reshape the corneal tissue with another laser. The procedure can be used for nearsightedness (as in Tiger Woods' case), farsightedness and, in some cases, astigmatism.

But the much-touted procedure is not for everyone. Those who have a misshapen cornea or excessively thin cornea, who have early cataract formation or big pupils, who have dry eyes, or underlying conditions such as lupus or rheumatoid arthritis, should be ruled out,"said Dr. Norman Saffra, director of ophthalmology at Maimonides Medical Center in New York City.

Source-The Washington Post.


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