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Dr. Herbert Nevyas Targeted by Patient Web Site

Jo Wills published a narrative of Keith Wills' problems with Dr. Herbert Nevyas:  LASIK Gone Wrong - What Happened to Keith Wills...

Dr. Anita Nevyas Sues Patient After Damaging His Vision

Dr. Herbert Nevyas and Dr. Anita Nevyas filed a lawsuit against Dominic Morgan for operating a web site at LasikDecision.com, and obtained an injunction to prevent Dominic from publishing information about this case. IT IS ORDERED THAT, ON COUNT III...

Dr. Herbert Nevyas and Dr. Anita Nevyas Accused of Submitting Fraudulent Reports to the FDA

Nevyas, while operating under and IDE for the Nevyas laser, failed to report various complications or adverse events to the FDA. Data from Nevyas simply cannot be trusted, and now Nevyas data has helped Intacs get on the market. The potential consequences could be severe.

Dr. Anita Nevyas Target of FDA Criminal Complaint

I now call for an investigation by the Office of Criminal Investigation, for action which would: 1) Terminate all IDEs and stop Nevyas from performing LASIK. 2) Fine and otherwise sanction Nevyas for past improprieties. It is my sincere belief that only the FDA, or an equivalent governmental agency with power to investigate criminal behavior can properly evaluate and understand what these improprieties are. The civil justice system is not adequate to the task.

Keith Wills v. Nevyas Eye Associates - Report on Standard of Care Deviation

Dr. Nevyas breached the applicable standard of care by operating on this highly myopic patient with an excimer laser utilizing a treatment zone that was substantially smaller than the pupil size in dim light. Specifically, Mr. Wills' pupils measured 6.25 mm in dim light, while the laser treatment zone was only 5 mm in diameter. With this combination of high myopia and a relatively large pupil, the use of a comparatively small diameter laser treatment zone was highly predictable to cause Mr. Wills to develop the residual visual problems from which he continues to suffer. Moreover, this specific situation (i.e. high myopia and large pupil diameter relative to laser treatment zone) was well known, even in 1997, to result in the likely outcome of permanent problems of glare, halo, starburst, and ghost imaging phenomena.

Dominic Morgan v. Nevyas Eye Associates - Report on Standard of Care Deviation (2)

In review of Dr. Salz' extensive examination and conclusions, I am of the opinion in complete agreement with Dr. Salz to the best degree of medical probability that the care rendered by Dr. Anita Nevyas-Wallace on behalf of Dominic Morgan fell below standard for LASIK surgery at the time. Indeed, I completely agree with Dr. Salz that Dr. Nevyas-Wallace failed to appropriately screen Mr. Morgan and exclude him as a viable candidate for LASIK surgery based on his extensive prior ophthalmologic history which would have predicted a less than optimal result, as he has ultimately experienced with the surgery performed by Dr. Anita Nevyas-Wallace.

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.

Dr. Anita Nevyas Target of FDA Regulatory Complaint

If the Nevyas Excimer Laser gains market approval from the FDA on the basis of improper data submission from its sole investigator, Nevyas, the results could be catastrophic. LASIK is an extremely popular operation, and some estimate over one-quarter of the North American population are potential patients. If a rogue device were to gain entry to this billion dollar market, where improper data could lead to it being used in favor of properly approved LASIK devices, the damages could be unimaginable.

Cheryl Fiorelli v. Nevyas Eye Associates - Report on Standard of Care Deviation

It is my opinion, to the best degree of medical probability, that Dr. Anita Nevyas-Wallace deviated from acceptable standards of care in her surgical judgement in selecting Ms. Cheryl Fiorelli as a candidate for LASIK surgery given her extremely high myopia and astigmatism. The failure to obtain corneal pachymetry to accurately assess comeal thickness preoperatively even in 1997 was substandard. The creation of the LASIK flap was complicated by microkeratome failure and stoppage both on the forward and reverse passes as documented in the medical record. Actually, a nurse was controlling the foot pedals of the microkeratome and not the operative surgeon. Moreover, an unapproved laser ("black box laser") was used to perform the Excimer Laser ablation.