Medical Device Daily Executive Editor

Somewhat more than 95% of those who have received the corrective eye procedure known as Lasik are "satisfied with their new vision," according to a recent survey finding from the American Society of Contact and Refractive Surgery (ASCRS; Fairfax, Virginia), and a statement that Medical Device Daily reported on yesterday in a "Briefly Noted" item (March 26, p. 5).

And in the ASCRS press statement citing this statistic, the organization's president said that there is "solid evidence in the ... scientific literature" concerning this "exceptionally high level of satisfaction" with the procedure.

But is "satisfaction" the same as being happy with the results? And what about the nearly 5% who may not be satisfied or perhaps are very dissatisfied?

Such questions suggest a problematic, and possibly unacceptable, level of problems with the procedure called "flap and zap" in its first development because involving cutting a corneal flap and then zapping the eye with a laser.

And these are some of the questions likely to be asked next month, on the second day of a two-day meeting, April 24 and 25, of the Ophthalmic Devices Panel of the FDA's Medical Devices Advisory Committee.

The April 25th session will focus on what the FDA announcement said will be a discussion of "general issues concerning the post market experience with laser-assisted in situ keratomileusis (LASIK)" as well as phakic intraocular lenses.

The Lasik "issues" are fairly well known, ranging from the visual side effects of glare and halos to, very rarely, loss of vision.

Rick Wise, device analyst with Bear Stearns, issued a note on the panel meeting saying that "Aside from visual side effects after Lasik surgery, we expect the FDA review will include psychological setbacks (with an emphasis on depression). "

He said that those having the Lasik procedure normally sign consent forms "which illustrate a myriad of risk factors ... mainly limited to the patient's vision rather than potential emotional and quality of life issues."

But he added that one possible fall-out from the hearing could be a requirement by the FDA that these consent forms include the possibility of "psychological" risk factors, such as depression.

"Since 1990, the industry has been addressing Lasik risk factors through improved technology and training," according to Wise's note, "and the meeting's impact will likely be a neutral for Advanced Medical Optics [Santa Ana, California] (34% of sales), Alcon [Huenenberg, Switzerland] (~1%), and Bausch & Lomb [Rochester, New York] (6%). We would be surprised if testimonials at the hearing resulted in a decrease in procedures, as most refractive surgeons we have spoken with believe their patients are well informed of post surgical risks."

Wise reported that from 1996-2006, FDA received about 150 patient complaints regarding Lasik. And he quotes the industry statistic of up to 96% procedural satisfaction defined as a person's likelihood of recommending the procedure to someone else.

"[H]owever, given the significant cost ($5,000-[$]6000 for the treatment), patients who experience issues with Lasik appear to be more aggressive in expressing their dissatisfaction ... . Still, post-surgical Lasik complications remain small and unlikely to alter market dynamics."

Larry Biegelsen, med-tech analyst with Wachovia Securities, reported that the patient satisfaction study by ASCRS will be presented at the organization's annual meeting in Chicago on April 7. He noted also that the FDA in 2006 organized a task force to design a clinical trial investigating quality of life issues following Lasik and that the National Eye Institute of the NIH is conducting a pilot study on the procedure.

The first day of the ophthalmic panel meeting will focus on discussing, making recommendations and voting on a premarket application from Visioncare Ophthalmic Technologies (Saratoga, California) for an implantable miniature telescope (IMT).

The IMT device is a visual prosthetic comprised of a small telephoto lens that enlarges images and serves to reduce the blind spot resulting from macular degeneration.

Specifically, it is indicated for monocular implant in patients with stable, moderate-to-profound central vision impairment due to bilateral central scotomas associated with end-stage macular degeneration with geographic atrophy or disciform scar, foveal involvement, and cataract.

Because reducing peripheral vision, the device is installed in on eye. It corrects visual field for intermediate and distant images, with the user needing external correction for near-field vision in that eye.

VisionCare went before an FDA panel in July of 2006, armed with data from a Phase II/III clinical trial of the device, but that data failed to win a recommendation for an approval at that time (Medical Device Daily, July 21, 2006).

The two-day session will be held at the Gaithersburg Holiday Inn, Gaithersburg, Maryland.

Global Harmonization document available

FDA has reported the availability of a final document from Study Group 4 of the Global Harmonization Task Force (GHTF), representing, it said, "a harmonized proposal and recommendation ... that may be used by governments developing and updating their regulatory requirements for medical devices." FDA said the document is intended to provide information only and does not describe current regulatory requirements [and that] elements of this document may not be consistent with current U.S. regulatory requirements.

Study Group 4 was tasked with the responsibility of developing guidance documents on quality systems auditing practices and it developed "Guidelines

for Regulatory Auditing of Quality Management Systems of Medical Device

Manufacturers Part 3: Regulatory Audit Reports,'' to provide a structure for audit reports used in multiple jurisdictions, promoting consistency and uniformity and should assist the auditor in preparing a report for use by multiple regulators and/or auditing organizations.

"Acceptance of audit reports by multiple regulators should eventually reduce the number of audits for manufacturers."

FDA said that as a result of receiving "several comments" on the document, first released in February of 2007, GHTF made clarifying changes.