Introduction of Issues for Excimer Laser Guidance

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Division Update

A. Ralph Rosenthal, M.D.

Director, Division of Ophthalmic Devices

DR. ROSENTHAL: Dr. McCulley, I just have one update, and that is to introduce you to a new Medical Officer who joined us in September, Dr. Sheryl Berman, who did her residency at Washington Hospital Center and has been working in the Washington area for the past several years and has now elected to come and work with us. She has an insightful mind and will provide a great opportunity for us to expand our Medical Officer Reviews.

DR. McCULLEY: You won't have to do primary reviews anymore  Medical Officer Reviews?

DR. ROSENTHAL: I have asked her to get up to snuff within 6 weeks so that  I don't know. We'll see.

Other than that, we have had a very productive year, and I think the panel should be aware of the enormous amount of work that has been done by this very small Division over the year and to whom I am eternally grateful for their diligence and high performance.

DR. McCULLEY: Well, certainly, the reviews that have come to us have been excellent, so from our standpoint, we appreciate the work.

Jim Saviola, Chief, Vitreoretinal and Extraocular Devices Branch, for an update.

Branch Update

James F. Saviola, O.D.

Chief, Vitreoretinal & Extraocular Devices Branch

DR. SAVIOLA: Good afternoon.

We passed out during the break the copy of the Public Health Notification to the panel dated September 25th, and also an October 13th follow up sheet. Did everybody receive that?

Okay. My update primarily concerns that particular notification.

It generated quite a bit of interest, and in response, the Branch wrote this one page, October 13th memo, and there are copies available at the front of the room for those who are interested in looking at that.

This was mailed to over 40,000 addresses on a purchased mailing list. The Office of Surveillance and Biometrics, OSM, coordinated this whole mailing and the process of issuing the health notification, and Ms. Carol Herman was the person in that office whom we worked with.

If people on the panel did not receive a copy, it was primarily targeted to eye care practitioners who dispense contact lenses  and I also did not receive a copy where I work or at home, so I must not have been on the right mailing list  but then again, I just fit contact lenses, I don't necessarily dispense them. A copy is available on the Center web site at

I want to touch on a couple questions that might have been in some people's minds in the aftermath of this notification. The primary response we got back from people was trying to find out which particular lenses we have cleared regarding tinted lenses and orthokeratology lenses, and why did we not include the approved lenses in the notification.

The answer to that was that we did not want to appear to be promoting any particular firm's products; we didn't want it to seem like we were advertising in this notification.

As we were going through the necessary review to issue this, there was in fact a second firm that received clearance for a theatrical tinted or an opaque tinted lens. This fact demonstrates that we are in a very dynamic environment with these manufacturers.

There is a feeling that having a list of approved suppliers, rather than a list of illegal firms, is more of a positive reinforcer, and that maintaining two lists creates a greater risk of miscommunicating a firm's status at any given time. If a firm had not received a clearance a week or a month ago, and we had a nonapproved list, that would change as we updated the approved list, so we would have twice as much to manage.

We are working with a number of firms to try to bring them into compliance. While I will refrain from mentioning any nonapproved firms specifically, I will state that at the moment, there are not any firms that are approved illegally marketed or so called after market tinted lenses  those are lenses which are purchased clear and then sent to a tinting house to have the color added to the lens  but I do expect that to change in the next few months.

Another question that has been considered by some is since these products have been out on the market for many years, why did FDA take action now. Well, this is sort of a tough question to answer, and the answer does have many parts. Our primary target for this notification was not the major manufacturing firms. The firms we are interested in are the firms that advertise over the web and other smaller firms that provide this after market tinting service. And there are a large number of this particular operations. There are limited resources to investigate and develop compliance cases against these offenders. That is a big issue as to why our efforts were hampered in trying to do this individually.

The increase in the number of firms is also an issue that was factored into our decision to issue a notification to practitioners and dispensers and notify them of the potential health risks associated with these tints.

We are also trying to maintain a level playing field, and that is a continuous effort. When a firm which has a legally approved device promotes their product in the marketplace, and there are unlawful competitive firms that are also promoting their device but have not received clearance, then we are somewhat forced to take an action.

The follow up information sheet noted specifically that the theatrical tinted lenses by Wesley Justin [ph.], Wild Eyes, are legally clear to be marketed by FDA. When we evaluate these types of tinting processes, we look at the manufacturing method that the firm is using to incorporate the tint into the lens as well as the specific tints that they are using. After that point, the firms are able to add additional tints which have been listed as safe to be used with contact lenses and create different color patterns.

The second firm that we cleared was the C.L. Tinters [ph.] firm out of Finland, and they also market a theatrical tinted lens called Crazy Lens.

Another question that might be in some people's minds is why combine the orthokeratology issue with tinted lenses; they seem somewhat separate from each other. The notification mailing was an efficient and economic vehicle to inform practitioners and dispensers of two issues which are very similar from a public health standpoint. In both the tinted lens and the ortho k lens case, the agency does not really have any good data available regarding the actual injuries associated with these devices, yet the potential for injury does exist.

By raising the general awareness level as to the potential for injury, we hope to accomplish two things. First, we hope to receive reports under MedWatch that will allow us to consider any appropriate follow up activities and to gather more data on this issue. Second, we hope to spur the currently violative firms to take action and to work with us to become compliant. If doctors have a choice between an approved device and one that is not approved, we hope they will choose the approved device for their patients. This is already happening with firms coming to us and working with us to gain appropriate clearances.

I don't want to reread this whole thing, but an important point to consider in how you can know for sure whether or not a device you are interested in purchasing is FDA approved is to request from the manufacturer a complete copy of the lens labeling, which includes the package insert, the practitioner's fitting guide, as well as the patient information booklet. The information contained in those documents will give you some idea of whether or not they are trying to pitch something which may or may not have a clearance from us.

That concludes my remarks. Does anybody have any questions?

DR. McCULLEY: Questions from the panel?

Dr. Ferris?

DR. FERRIS: Because this is a dynamic, changing area, have you thought about creating a little web site for this so that you can update it without having to put out yet another mailing?

DR. SAVIOLA: We haven't explored the possibility of putting this information up on a web site. I do plan to update the fax notifications periodically as we get additional firms cleared.

DR. McCULLEY: Other questions, comments?

[No response.]

DR. McCULLEY: Thank you very much.

Donna Lochner will report tomorrow in the open session.

Now, for a Branch Update before we go to the discussion to follow, Morris Waxler, Chief of the Diagnostic and Surgical Devices Branch, will report.

Branch Update

Morris Waxler, Ph.D.

Chief, Diagnostic & Surgical Devices Branch

DR. WAXLER: Good afternoon.

First, I want to thank the panel for your presence here and your help over the last year, and also, I'd like to thank the Branch, which I introduced to you this morning, and I would like to quickly introduce them in general, without reading each of their individual names. They have done a marvelous job, and you will see that when I give you the details.

In addition, I would like to thank the medical officers and Dr. Rosenthal as well for all the hard work that it has taken to get through this particular year.

First, I want to give you an update on the status of the PMAs that were reviewed by the panel previously. P97005 was approved by FDA on July 30, 1998. This PMA is for the single unit Kremer excimer laser system, Serial Number KE940202 for the LASIK correction of primary myopia ranging between  1 and  15 D with or without astigmatism ranging from 0 to 5 D. Data on safety and effectiveness from a multicenter clinical trial will be needed to market additional units of this laser.

P970049 for Autonomous Technologies' refractive surgery laser unit remains under review.

P9300116, Supplement 7, for VISX for hyperopia, remains under review.

P970001, for Emory Vision Correction Center's laser for LASIK, remains under review.

Members of the panel asked FDA a couple of sessions ago to review the data on the relationship between hormone replacement therapy and refractive surgery outcomes. We asked Dr. Rhonda Ballum [ph.] in the Office of the Commissioner to review the published literature and the data submitted to the agency in the PMAs. Unfortunately, Dr. Ballum could not be here today to summarize her review. I will summarize here conclusion.

There appears to be no or minimal effect of HRT  that is, hormone replacement therapy  on outcome. She concurs with the conclusion drawn by Serander & Peak [ph.] that both hormone replacement therapy and oral contraceptives may affect the eye during the period of dosage determination as the body adapts to an altered hormonal level. However, once they hormonal levels are stable, there should not be any further effect on the eye.

Due, however, to the lack of available research on the subject of postmenopausal women on HRT versus those not on HRT, this continues to be a confounding variable, and one that is worth of a well controlled sub study.

An independent statistical review of the data previously presented by Autonomous Technologies shows that it is age and desired correction that are highly associated with outcome, not HRT. We plan to seek your advice at another meeting of the panel about how to or if we should incorporate this information into our revised guidance for refractive surgery lasers.

Now to our workload. Well, it has been a busy year. First, on IDEs, our Branch has reviewed, with the help of other staff in the Division, 597 submissions, 551 of which were supplements to FDA approved IDE clinical trials, 27 of which were submissions of new IDEs, and 19 of which were amendments to disapproved IDEs. Of the 551 supplements, 229 were submitted by manufacturers, 237 were submitted by sponsor investigators, and 85 were submitted by sponsor investigators of so called "black box" lasers.

Of the 27 submissions of new IDEs, 5 were submitted by manufacturers, 20 by sponsor investigators and 2 by "black box" sponsor investigators.

The number of manufacturers submitting IDEs has not increased from the previous year, and the number of "black box" applicants has decreased to 5.

The number of PMAs and PMA supplements under review in the last fiscal year was 9. A fiscal year, for those of you who do not know, is the fiscal year ending on September 30, 1998.

I'll be glad to entertain questions, except on HRT.

DR. McCULLEY: Thank you.

Does anyone have any questions or comments for Dr. Waxler?

[No response.]

DR. McCULLEY: Okay. Are you ready to stay on the hot seat?


Introduction of Issues for

Excimer Laser Guidance Discussion

Morris Waxler, Ph.D. and Malvina B. Eydelman, M.D.

DR. McCULLEY: Dr. Waxler is going to introduce the issues for excimer laser guidance discussion. We have three that have been provided to us in writing, and I understand there is a fourth.

DR. WAXLER: Correct  and I agree whole heartedly, Dr. McCulley, with your earlier comments about our focus on these three issues.

The fourth issue was brought to my attention in several ways, and Dr. Rosenthal and I agreed that it was timely to bring it to your attention. I think it will be fairly straightforward and will be important to hear your discussion of that issue.

DR. McCULLEY: Can I ask you for some help to get your guidance  we are scheduled to go until 5:30, and it is approximately 2:50 now. Do these three issues and the fourth, time available, require in your estimation, prior to beginning, equal time? My concern is that we could end up with very little time for the third issue if we don't try to allocate the time to the three. We have often done this with questions in the past; we didn't for this.

DR. WAXLER: Well, I'll have to defer to the chair and to his illustrious control of the panel.

DR. McCULLEY: No  that's an illusion.

DR. WAXLER: Well, you are a good illusionist. I don't know what to say. I think a lot depends on what the member panelists come up with in regard to each of these issues. I think each one has its own meaty areas; some, in my estimate, will take a lot shorter. But I am just guessing myself, so I wouldn't be much help to you.

DR. McCULLEY: It would be my guess as well.

We'll take them in the order that they are listed  Dr. Belin first, Dr. Stark second, Dr. Bullimore, third. I am not sure how you want to introduce these. Do you want to introduce the issue and the question and then have the assigned person give his evaluation, and the panel can discuss  we'll do them one at a time.

DR. WAXLER: Sure. And I wrote a little preamble to give the context to the panel and the staff and the audience, that maybe they should hear.

DR. McCULLEY: We have to allot time for that, too.

DR. WAXLER: And I spent hours working on these two paragraphs  

DR. McCULLEY: We have to do it, then.


DR. WAXLER: I appreciate it.

Essentially, we are asking the panel to discuss the development of extensions of the guidance for refractive surgery lasers and to make recommendations to the agency on clinical outcomes for the determination of safety and effectiveness. But we want it for the full range of myopia and hyperopia, so there are three issues.

The current guidance is limited, as you know, to moderate myopia, and does not cover astigmatism; and also, it suggests the 250 micron residual amount of corneal tissue that should remain. So we asked the three panelists, Dr. Belin, Dr. Bullimore and Dr. Stark, to talk about those issues, and if you like, I will introduce the first issue from here, and then, when you are ready, we can go to the second one.

DR. McCULLEY: Why don't we do that, and let me just remind everyone that if we are going to end at 5:30, which I don't particularly care  I am here tomorrow, too  that we need to try to allot time and address the issues thoughtfully, but not belabor the obvious.

Okay. If you would like to read your first issue.

DR. WAXLER: The first issue is: should the percentages of effectiveness  that is, UCVA, and the percent of manifest refracted spherical equivalent  be a function of the diopter intended correction in order to provide reasonable assurance of effectiveness. If yes, then what percentages do you suggest?

I'll let Dr. Belin take the floor.

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