December 20, 2001

Dr. Anita Nevyas Target of FDA Regulatory Complaint

850 West Chester Pike, 1st Floor
Havertown, PA 19083

Tel: 610.789.0568

Steven A. Friedman, M.D., J.D., LL.M.
Physician and Attorney at Law

Internal Medicine and Chest Disease - Health and Corporate Medical Law

December 20, 2001

Office of Device Evaluation
Division of Ophthalmic Devices
Food and Drug Administration HFZ-460
9200 Corporate Boulevard
Rockville, MD 20850

           RE:   Nevyas Excimer Laser ("Investigational Device")
Investigational Device Exemption (IDE):  G970088
Protocol:  NEV-97-001 and subsequent (e.g. NEV-097-002

Dear Sirs:

I write to summarize improper data submission, violation of FDA protocol, and violation of FDA regulations.

I have learned of these improprieties through my representation of Mr. Dominic Morgan, who had bilateral LASIK performed by Dr. Anita Nevyas-Wallace of Nevyas Eye Associates ("Nevyas") April 23, and 30, 1998, and is now on Social Security Disability due to legal blindness:

  1. Mr. Morgan responded to a misleading radio advertisement of Nevyas for LASIK, and came to Nevyas on March 10, 1998.  He was age 37, had marked retinopathy of prematurity, prior strabismus surgery, and reported that, to his knowledge, he had never seen better than 20/50 either eye.
  2. Nevyas did not correct misrepresentations made in the radio advertisement.  Neither did Nevyas make any attempt to verify stable manifest visual acuity during the prior year, as was required by FDA protocol.
  3. His pre-op best corrected visual acuity was first allegedly measured as 20/40-2 in both eyes, and then allegedly measured as 20/40- in both eyes.  With spectacles he measured 20/50 in both eyes.  In a Complex Case Form subsequently sent to Nevyas to Dr. Jeffrey Machat (TLC Toronto Laser Center), his pre-op best corrected visual acuity was called 20/50+ in both eyes.
  4. He was subjected to LASIK for -6D ("low") myopic astigmatism April 23 and 30, 1998, using the Nevyas Excimer, then and now an "Investigational Device" regulated by the FDA.
  5. Four days after left eye LASIK his visual acuity was measured as 20/70.  Four days after right eye LASIK both eyes measured 20/60-.  His vision thereafter worsened to 20/200 both eyes and he has ghost images.
  6. Mr. Morgan was assured by Nevyas that his eyes could be "fine tuned" by repeat LASIK, as promoted by Nevyas in a half-hour TV advertisement during that time, but that he would have to wait.  Nevyas did not correct misrepresentation made in the TV advertisement, and Mr. Morgan awaited the "fine tuning".
  7. Mr. Morgan remained under the care of Nevyas through March 27, 2000, almost 2 years post-LASIK.  During that time he felt that he was being encouraged to not return.  He did visit other ophthalmologists seeking second opinions (Albany Lions Eye Institute, Wills Eye Hospital, John Hopkins-Wilmer, and others) and reported their findings to Nevyas.

My concerns are:

  1. Despite 21 C.F.R. 812.7 which prohibits promoting an investigational device until after the FDA has approved the device for commercial distribution, Nevyas promoted the Nevyas Excimer Laser by frequently repeated radio advertisements, by a frequently repeated half-hour TV advertisement, extensive internet web site advertisements and elsewhere.  These advertisements were misleading.  They misrepresented the capabilities and results of Nevyas.  The radio and TV advertisements did not state that the Nevyas Excimer Laser was and is investigational.
  2. In violation of protocol NEV-97-001 inclusion criteria requiring both eyes be 20/40 or better, LASIK was performed in both eyes.
  3. Protocol NEV-97-001 inclusion criteria required one year of stable manifest refraction, and this was not verified.
  4. Protocol NEV-97-001 exclusion criteria for clinically significant abnormality on ophthalmic examination should have excluded Mr. Morgan because of his marked retinopathy of prematurity.
  5. Nevyas did not report Mr. Morgan's outcome to the FDA as either a complication or adverse event, despite this being observed by the doctors, reported by the subject, and required by the FDA protocol.  This was a blatant attempt to skew statistics being reported to the FDA.
  6. Nevyas has claimed that, even though not reporting Mr. Morgan as a complication or adverse event, he is included in the statistical compilation of outcome data.  This is another false misrepresentation.

Examination of IDE Supplement No. 18, The Annual Report for IDE G970088 dated March 14, 2001 (which incorporated the October 1999 report) reveals that Mr. Morgan was deliberately omitted from Nevyas' statistical compilation of outcome results:

  1. Nevyas claimed to report all eyes treated between 2/19/98 through 111/22/99 (see report p.9).  Mr. Morgan should have been included in the group with low myopic astigmatism.
  2. Table 1.1.E-4 (Patient Accountability, Low Myopia) shows a "loss to follow-up" rate of 27.2 to 30% at 18 and 24 months.  Although Mr. Morgan was encouraged to become lost to follow-up (presumably so he could be replaced as a protocol deviation - see report page 8), he was not lost to follow-up.  However, other dissatisfied subjects may have been deliberately lost to follow up.
  3. Table 1.1.E.1-9, (Key Safety and Efficacy for low myopia) shows no subjects reported with best spectacle corrected visual acuity (BSCVA) worse than 20/40 after 1 month.  It also shows no subjects reported with loss of more than (>) 2 lines BSVCA after 3 months.  Nevyas has conceded that Mr. Morgan lost at least 4 lines.
  4. Table 401 (Adverse Event Summary) shows no subjects reported with decrease of BSCVA greater than (>) 10 letters not due to irregular astigmatism.
  5. Table 4-1 also shows no subjects reported with ghost images.
  6. Similar non-reporting is seen in the October 1999 report which was incorporated into the March 14, 2001 report, including:
  1. Table 1.1.E.1-1 (Key Safety and Efficacy for all eyes) shows no subjects reported with BSCVA worse than 20/40 after 1 month.  It also shows no subjects reported with loss of more than 2 lines BSVCA at any time.
  2. Table 1.1.G-1 (Complications) shows no subjects with ghost images despite Mr. Morgan's complaint.
  3. Table 1.1.G-2 (Adverse events) shows no subjects with decrease in BSCVA > 10 letters not due to irregular astigmatism.
  1. Reminiscent of the "big lie" technique, Nevyas' web site advertisement (as of January 13, 2001) claims 100% of myopic patients with 4 to 6 diopter deficits saw 20/40 or better (Mr. Morgan had 6 diopter deficit).  (See web site advertisements.)

Lastly, I want to emphasize Nevyas' history of not reporting to the FDA:

  1. Nevyas began using the Nevyas Excimer Laser for LASIK in January 1996.
  2. By February 27, 1997 Nevyas had done 147 LASIK myopia procedures in 70 patients (i.e. had "fine tuning" in 7 patients).
  3. Protocol NEV-97-001 granting Nevyas an Investigation Device Exemption was dated to March 18, 1997.  Everything done before was completely unregulated by protocol, and possibly much done after.
  4. On April 4, 1997 Nevyas told FDA Investigator Steven F. Kane (Philadelphia office) that the Nevyas Excimer Laser is a "Custom Device" not subject to FDA regulation or reporting.
  5. On June 30, 1997 Nevyas prepared, but would not sign a FDA 463a form.  In that declaration he stated doing LASIK on 252 patients as of that date, and stated his claim that the Nevyas Excimer Laser was not subject to FDA regulations.
  6. Thereafter Nevyas has continued to do LASIK, supposedly under Protocol NEV-97-001.  Nevyas has managed to prolong its "investigation" under "protocol" for about 4 years, at $2,500 per eye.  Nevyas has widely advertised and promoted its investigational device in defiance of 21 C.F.R  812.7, which specifically forbids such promotion until after the FDA approves devices for commercial distribution.  Nevyas has also purchased a FDA-approved Summit laser, and may be using it to manipulate results.

Vision is precious to all of us.  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.

In the end analysis, Nevyas stands to gain (and the public loss) if the Nevyas Excimer Laser can be licensed to various companies for commercial distribution.  The only source of data regarding the safety and efficacy of the Nevyas Excimer Laser is Nevyas.  Nevyas is submitting improper data and violating FDA protocol and regulations.

Please contact me for any questions.

Sincerely yours,
Steven A. Friedman

Posted by Admin at December 20, 2001 01:41 PM