FDA Says 45% of LASIK Surgery Patients Report Side Effects

October 21, 2014 — The FDA is warning that nearly half of people who undergo LASIK laser eye surgery report at least one persistent side effect.

The most serious complications of LASIK eye surgery include problems driving at night or in sunshine, debilitating vision symptoms (starbursts, glare, ghosting, or halos), and severe dry eye.

According to the FDA:

• 45% of patients who had no visual symptoms before LASIK reported at least one visual side effect 3 months after surgery.
• Less than 1% of patients had problems that interfered with normal daily activities.
• The most common complication was “halos” — 35% of patients who had no halos before LASIK reported halos 3 months after surgery.
• 30% of patients who had no dry eye problems before surgery reported symptoms afterward (consistent with previous studies).

The “LASIK Quality of Life Collaboration Project” was conducted by researchers from the FDA along with the National Eye Institute and the U.S. Defense Dept. Conclusions of the study were based on a study that used questionnaires to assess visual symptoms in patients before and after LASIK surgery.

In May 2009, the FDA issued a letter to LASIK eye surgeons, warning against improper promotion and advertising practices. The FDA was concerned that surgeons were not providing patients with adequate information, misleading them about the safety risks and limitations of LASIK surgery. The FDA issued another warning about misleading ads in 2012. Click here to read more.

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