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Medtech Miracles and Tragedies: Michael Patterson, Dean Andrew Kantis, and Roger Davis

Michael Patterson, Dean Andrew Kantis, and Roger Davis Some patients who say they have been harmed by LASIK procedures say they suffer double vision (illustrated above). Image courtesy of Roger Davis.

Laser-assisted in situ keratomileusis (LASIK) procedures have freed many patients from eyeglasses and contact lenses. But some aren’t so lucky.

“LASIK ruined my life,” says Atlanta resident Michael Patterson, who underwent the procedure in 2000. And he’s not alone.

Exact numbers are hard to find, but some patients say they have suffered negative effects ranging from double and blurred vision to severe dry eye as a result of LASIK procedures, which use an excimer laser and microkeratome or laser keratome to reshape the cornea.

But the American Society of Cataract and Refractive Surgery (ASCRS) defends the procedure. “Based on substantial research and data collected over decades, ASCRS is convinced that LASIK is safe and effective, and offers a viable option for dramatically improving the quality of life for millions of qualified candidates,” the group writes on its Web site.

“If I wasn’t damaged by LASIK, I’d probably find it impossible to believe,” says Roger Davis, an academic psychologist from Poplar Bluff, MO. Davis has experienced some degree of “ghosting” in his right eye since undergoing LASIK in 1998. He created the Web site VisualSimulations.com to simulate the vision problems experienced by himself and other patients who say their vision was damaged by LASIK.

Dean Andrew Kantis says he has experienced dry eye and has no 3-D or stereoscopic vision since undergoing the procedure. “Everything I see now thanks to LASIK is one dimension, like a painting but smeared,” he says. “I have no contrast sensitivity. I can’t see sharp edges on anything or anyone any longer.”

In 2009, Kantis, an outspoken critic of LASIK, shared his story with Morris Waxler, the former CDRH Diagnostic and Surgical Devices branch chief who led the review team that granted FDA approval for the first lasers used for LASIK in 1997. Waxler has since reexamined the PMA data he relied upon to approve the devices and has twice petitioned FDA to withdraw approval for all LASIK devices. FDA ultimately denied Waxler’s first petition, saying he had not met the standard for PMA withdrawal and that the agency did not believe a public health advisory with a voluntary recall was warranted.

“How can they sleep at night knowing that they did this to innocent people, families, parents, human beings?” Kantis asks. “How could you knowingly put money first and apathy and sympathy for human beings’ wellbeing last, and then continue to do this and cover the known permanent injuries up?”

 

Continue to Are These Medical Devices Too Dangerous? 

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