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FDA Issued Inspection Report of Nevyas Eye Associates facility dated 11/02/1998:
PAGE 1 - There was no documentation to show that the Cl notified the IRB about all amendments, changes or significant deviations to the protocol [per IRB requirements].
PAGE 2 - Previous inspection on 6/30/97 of this facility revealed the firm continued to use the laser to perform eye surgery without an approved IDE, planned to use the laser or new treatment procedures not included in the firms disaproved IDE and verified that the firm had received a disapproval letter from CDRH/ODE notifying them that use of the laser to treat patients was a violation of the law.
PAGE 5 - The current inspection revealed Clinical Investigator currently performs Myopic procedures under an approved IDE however, procedures are being performed on IDE patients prior to approval date, the date is missing on a consent form, consent forms were signed by patients after surgery date and procedures were performed on IDE patients which are outside the IDE with an unidentified laser at an unauthorized location.
PAGE 6 - Persons interviewed, individual resposibilities, & operations.
PAGE 7 - [Redacted] initial IDE submission was disapproved May 8, 1998. He was granted conditional approval on August 7, 1998. As [Redacted] addressed various issues presented in letters from FDA CDRH/ODE he was granted more uses of the IDE.
PAGE 8 - [Redacted] built the [Redacted] for [Redacted] however, [Redacted] owns it. He was responsible for submitting the information for the IDE, in conjunction with and eventually Pre-Market Approval for the device. He is therefore a Sponsor/Clinical Investigator.
PAGE 9 - These procedures were performed well before approval was granted. [Redacted] stated he had been doing this procedure previously and no one had told him the procedure couldn't be performed as of 8/28/97.
PAGE 10 - Consent form for [Redacted] was not signed. There was no way of determining whether consent was obtained before or after surgery to the right eye on 12/4/97, due to lack of a date next to patients' signature.
PAGE 11 - [Redacted] had [Redacted] enhancements performed which is a condition not indicated in the [Redacted]. Additionally, the procedures were performed with a laser that is not indicated in the study and the surgery was performed at a location that is not identified in the protocol.
PAGE 12 - There was no evidence of a patient information and consent form in the file for this hyperopic enhancement.
PAGE 13 - 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].
PAGE 14 - According to a letter dated August 27, 1997, EXHIBIT #8 from the IRB, [Redacted] is required, in addition to other items, to report to the IRB any new advertisements, recruiting material, serious adverse events, amendments or changes to the protocol or significant protocol deviations. Observation # 6 represents a significant protocol deviation and should have been reported to the IRB for approval prior to implementation.
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FDA Issued Inspection Report of the Nevyas' facility dated 05/10/2001:
PAGE 1 - 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.
PAGE 2 - An inspection conducted on 12/2/96 revealed the firm had assembled a single excimer laser and was using it to perform [Redacted] eye surgery on at least 120 patients without an approved IDE.
PAGE 3 - Persons interviewed, individual resposibilities, & operations.
PAGE 4 - According to a letter from the FDA to [Redacted] dated 1/20/99 EXHIBIT #1, the investigation is still limited to one location, listed in bold above however, the population has grown to 1015 subjects (2030 eyes):
PAGE 5 - For example, the FDA granted your firm an increase in the number of subjects you could treat with your investigational device on Jan. 20, 1999. IRB Annual Review dated 7/29/00 does not indicate the IRB knew about population increase. The IRB did not approve the population increase until August 28, 2000, 20 months later.
PAGE 6 - EXHIBIT #6 is an Investor Agreement which was signed by [Redacted] Sponsor/Clinical Investigator and [Redacted] Co-Investigator. The agreement indicates, among other things, the clinical investigators agree to promptly report to the IRB all changes in the research activity. The clinical investigators failed to report the increase in the number of study patients, granted by the FDA, to the IRB in a prompt manner.
PAGE 7 - I explained to [Redacted] that he did not have IRB coverage from 8/3/2000 until 8/29/2000. [Redacted] stated his consultant, [Redacted] was ill for several months and she normally took care of report submittals and updates which is why the firm was tardy with reporting updates.
PAGE 8 - [Redacted] stated it may appear that patients signed the consent forms one day after surgery however, this is certainly not the case and is not the way things are normally done. He indicated this was a mistake made by someone on his staff.
PAGE 9 - 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]. This observation was carried forth to the current listing of objectionable conditions or practices. See FDA-483 observation #1 listed above on page #4 of this report.
PAGE 10 - All changes made to the protocol were documented by the investigator, dated, maintained with the protocol, however all changes were not approved by the IRB (see FDA-483 observation #1 listed on page 4 of this report).
PAGE 11 - According to records reviewed, the investigator did submit and obtain IRB approval of the protocol, modifications to the protocol (except as noted in FDA-483 OBSERVATION #1),
- Lists exhibits included with inspection report.
- Nevyases response to inspection.
"All adverse experiences have been reported to the sponsor-investigator, FDA, and IRB in accordance with 21 CFR Part 812", and "The occurence of all events and complications as defined in Protocol NEV-97-001 have previously been reported to FDA. No serious adverse events related to the Nevyas Excimer Laser have occurred in the study".
According to deposition by Anita Wallace, my visual problems post-lasik was not considered a complication or adverse event (I disagree!), even though she claimed the data regarding my situation was reported to the FDA. The charts submitted to the FDA listing adverse events and complications do NOT show data relevant to the number of medical malpractice claims filed against them during their study.
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The 2nd inspection resulted in an FDA483 issued by the FDA.
Although the records requested via the FDA's Freedom Of Information Act were redacted (edited), the FDA stated:
"There is too much information the general public should not be aware of, not only in the Nevyas' study, but in all studies". - Les Weinstein, CDRH Ombudsman
This second set was obtained from the FDA's Philadelphia Office, and included not only the Nevyas' facility of 05/2001, but that of Ed Sullivan (Exsull), builder of their laser (see above). The inspection was 2 years after the article written in the Journal of Refractive Surgery (Fall Issue - 1995):
Inspection Report of the Nevyas' facility dated 05/2001 (less edited):