In response to widespread reports of problems with LASIK eye surgery, the Food and Drug Administration (FDA) called a Special Hearing of the Ophthalmic Devices Panel on April 25, 2008 to address post-LASIK issues such as poor visual outcomes, debilitating post-LASIK dry eye, loss of quality of life, depression, suicidal thoughts, and a number of LASIK-related suicides. Thirty-one presentations were given during the open public hearing, many from patients suffering from long-term complications of LASIK. Among the proponents of LASIK...
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LASIK eye surgery volumes are declining. LASIK industry representatives blame the economy. LASIK critics attribute the decline to the Food and Drug Administration's (FDA) heightened scrutiny of LASIK, and public distrust of the surgery following media reports of widespread problems with LASIK. Especially hard hit are LASIK chains, sometimes referred to as "LASIK mills", such as LasikPlus and TLC Laser Eye Centers. TLC continues to advertise its "lifetime commitment" to patient follow-up care, yet the company's financial picture is grim,...
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September 5th, 2008 Dear Editor, Recently LASIK Newswire reported that a citizen petition was filed with the FDA to ban LASIK. The petition is based on substantial deception in the labeling and an unreasonable and substantial risk of injury. The FDA's own data from LASIK clinical trials is cited. The petition states, "A meta-analysis of Summaries of Safety and Effectiveness for the twelve lasers approved from 1998 through 2004 (exhibit B) found that six months after LASIK, 17.5% of patients...
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