The following documents were submitted to the FDA from 1997 through 2001 regarding the "Nevyas Investigational (Black Box) Laser"
The laser was built by Ed Sullivan who, according to the excerpt below, was already under scrutiny by the FDA.
"Ed Sullivan, doing business as ExSull, Drexel Hill, Pa, has been put on notice by the FDA that the agency regards him "clearly as a manufacturer with multiple manufacturing sites" subject to FDA rules and regulations and, if he makes another one of these excimer lasers "which are unapproved devices," he will be in violation of the federal Food, Drug and Cosmetics Act and subject to legal penalties, according to top-ranking FDA officials within the national Division of Enforcement." [as written in The Journal of Refractive Surgery - Volume 11 (5) * September/October 1995 * News and was found at the url address: http://www.slackinc.com/eye/jrs/vol115/news1.htm">http://www.slackinc.com/eye/jrs/vol115/news1.htm (no longer available).
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To view ALL DOCUMENTS listed below in one PDF (two parts), click HERE.
PAGE 1 - Prohibition of promotion and other practices. - 21 CFR. § 812.7
PAGE 2 - Protocol NEV-97-001: Myopia with or without astigmatism - Study Procedures.
PAGE 3 - Protocol NEV-97-001: Inclusion/Exclusion Criteria.
PAGE 4 - IDE Supplement - Question/Response.
PAGE 5 - Protocol NEV-97-001: Ethical and regulatory considerations.
PAGE 6 - Protocol NEV-97-001: Complications, Adverse Events, & Serious/Unanticipated Adverse Device Effects.
PAGE 7 - Protocol NEV-97-001: Inclusion/Exclusion Criteria Revision.
PAGE 8 - Protocol NEV-97-001: Screening for Refractive Surgery Eligibility.
PAGE 1 - PAGE 2 - PAGE 3 - FULL - Protocol NEV-97-001: Study Changes, Progress towards PMA Approval, Safety & Efficacy for Study Eyes (Notice the 100% for cumulative UCVA of 20/40 or better, the 0 counts for the BSCVA worse than 20/40 or better, or for the BSCVA worse than 20/25, 6 months after my surgery).
PAGE 1 - PAGE 2 - FULL - The FDA states "We continue to be concerned that your ablation is likely to have multifocal properties, which means that some light will be out of focus even at tine best focal plane".
PAGE 1 - PAGE 2 - PAGE 3 - FULL - Safety & Efficacy for Study Eyes, Page 1 (Notice the 100% for cumulative UCVA of 20/40 or better, the 0 counts for the BSCVA worse than 20/40 or better, or for the BSCVA worse than 20/25, 1 1/2 years after my surgery). The charts on pages 2 and 3 also do not show adverse events or complications.
PAGE 1 - The FDA states "There was no documentation to show that the CI notified the IRB about all amendments, changes or significant deviations to the protocol [per IRB requirements] prior to implementation"; "The firm is not complying with the Investigator Agreement which was signed and dated by the Clinical Investigator at the beginning of the Clinical Study"; and "There was a lapse of IRB approval for the protocol: NEV-97-001 from 8/3/2000 until 8/29/2000 according to IRB, lapse notices and the IRB annual reapproval letter".