Exposing the LASIK Scam

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 Post subject: Surgeons voice serious concerns with LADARVision
PostPosted: Wed Dec 14, 2005 1:16 am 

Joined: Sat Nov 26, 2005 1:23 pm
Posts: 2080
Eye World
Jan 2005

Lasers or surgeons:
What?s really the cause of high retreatment rates?

Sam Omar, M.D., medical director, Advanced Vision Institute, Longwood, Fla., said after he did about 40 cases with LADARVision between 2000 and 2001, he stopped using the machine due to both a high retreatment rate and poor outcomes.

?Alcon refused to supply their billing information showing retreatment rates on our LADARVision laser after I requested that they do so,? said R. Doyle Stulting, M.D., Ph.D., professor of ophthalmology, Emory University, Atlanta. Officials at Alcon said the information is readily available to individual surgeons. Alcon officials told EyeWorld that the information could not be used for clinical analysis because it is incomplete without surgical site data. They said they do send clinical teams to surgical sites if ophthalmologists suspect a problem with LADARVision.

Meanwhile, the FDA has contacted at least one surgeon to request information about the performance of the LADARVision.
Everette Beers, Ph.D., the FDA?s chief of the diagnostic and surgical devices branch in the division of ophthalmic and ENT devices, declined to comment whether there is an investigation into LADARVision.

LADARVision was recalled twice in 2000 and 2001, and in many instances the same machines were recalled, according to two FDA enforcement reports. The reason for the 2000 recall, which applied to 136 units, was that patients had an ?unsatisfactory vision correction due to error in ablation mask function.? The explanation for the 2001 recall, which affected 85 units, was that ?unanticipated laser pulses reaching the cornea will cause ablation of the corneal surface, which could result in a central corneal defect of about 1 mm in diameter.?

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Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato

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