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Nevyas Investigational Laser PDF Print E-mail

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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NOTES: Page numbers with an "l" designate the page as landscape. All BLUE font on this page designate links. Some PDF documents may require a decrease in magnification for better clarity.

PDF Documents (for high speed or download)

To view ALL DOCUMENTS listed below in one PDF (two parts), click HERE.

1997 Reports

PAGE 1 - Prohibition of promotion and other practices. - 21 CFR. ยง 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 9 -  PAGE 10 - Protocol NEV-97-001: Clinical Study Data Submitted to FDA.

1998 Reports

PAGE 1 - PAGE 2 - PAGE 3 - PAGE 4 PAGE 5 - PAGE 6 - PAGE 7 - PAGE 8 - PAGE 9 - PAGE 10 - PAGE 11 - FULL - Protocol NEV-97-001: Study IDE Supplement Annual Report

PAGE 1 - PAGE 2 - PAGE 3 - FULL - Protocol NEV-97-001: Study IDE Annual Report Supplement

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).

1999 Reports

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.

2001 Reports

PAGE 1 - PAGE 2 - FULL - Protocol Deviations & Summary of Complications and Adverse Events.

PAGE 1 - PAGE 2 - PAGE 3 - FULL - Nevyas Investigational Study charts submitted to the FDA.

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".