April 27, 2002

Dominic Morgan v. Nevyas Eye Associates - Report on Standard of Care Deviation (1)

Mr. Morgan states and it is confirmed on his patient history dated 3/10/98 that he came to the Nevyas Eye Associates because he heard a radio commercial on station KYW. I have reviewed the script of radio advertisements, the Nevyas web pages, and a promotional Videotape of a program that was shown on cable television and may have been distributed to patients. I have been told that all of these materials were used during the FDA investigation of the Nevyas Laser. None of these materials included the FDA required warning that the device is limited to investigational use only. The ads also represent that the procedure is safe, and in fact the TV ad shows a simulated blurred 20/200 vision quickly dissolving into a sharp 20/20 vision. There are numerous other representations that the procedure is safe and effective. If patients were responding to these advertisements and then were entered into the FDA study, that would represent a serious deviation from the standard of care and one that I am sure the FDA would be interested in these practices.
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