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Hyperopia capability ‘locked out’ on Nidek excimer
After reports of unapproved hyperopic LASIK surgery with the EC-5000, the company agreed to disable certain hardware and software on the laser.
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WASHINGTON — Nidek has “locked out” the hyperopia treatment capabilities on its EC-5000 excimer lasers in use in the United States following discussions with the Food and Drug Administration.
The company has sent service technicians to modify its lasers in the field in order to prevent practitioners from using the lasers for unapproved hyperopia applications. The Nidek EC-5000 is currently approved by the Food and Drug Administration (FDA) for treatment of myopia and astigmatism using LASIK and photorefractive keratectomy.
According to Ron Swann of the FDA’s Office of Compliance, the government was tipped off to the unapproved use of the refractive lasers for hyperopia treatments as they checked individual surgeon’s ads on Web sites and in other advertising venues. Ads stated that some doctors were offering hyperopia surgery with their Nidek machines – a procedure for which the EC-5000 is not approved.
Mr. Swann, as well as Everette Beers, PhD, chief of the diagnostic and surgical devices branch of the Division of Ophthalmic and ENT Devices of the FDA, also said they received complaints from doctors who informed the department that some Nidek laser owners were using the EC-5000 for hyperopia treatment.
Dr. Beers said the software lock-out and hardware block was a compliance issue, not a practice-of-medicine issue. The hyperopia block was instituted because use of the Nidek laser with the additional hyperopia software would modify it and adulterate the device.
“A physician has the option to use a device off-label, but he cannot modify the device,” Dr. Beers said.
He said that in discussion of the issue with the FDA, Nidek suggested the software lock-out and hardware block as a remedy.
After the discussion with the FDA, a letter from Nidek Vice President Hiroshi Okada informed doctors that the company was offering, free of charge, to install software security and hardware blocks “to assure the compliance status of your unit with current approved specifications and uses.” Nidek said it would conduct the service visit at the laser site, remove unauthorized components and install security devices to ensure the laser user’s site remains compliant with current product standards and FDA requirements.
Nidek also informed physicians that they would be keeping the FDA apprised of the security installation activities.
In a statement to Ocular Surgery News, Nidek spokeswoman Dawn Verhulst said, “Since 1971, Nidek has been dedicated and committed to its doctors, and providing high quality instrumentation to support the care they give and their businesses. In support of these tenets, Nidek strives to comply and work closely with the FDA for the good of the entire medical community and the patients it treats.”
Physician outcry
The modification of the EC-5000 has spurred some surgeons to accuse the FDA of overstepping its bounds by restricting the practice of medicine. Philadelphia-area ophthalmologist and LASIK surgeon James S. Lewis, MD, has gone so far as to express his opinion on his Web site, http://www.jameslewismd.com/crypto.html.
On the Web site he posted an open letter titled “The FDA has lost its way.”
“Years ago I welcomed the FDA branding of devices and medications. They stood for equanimity and honesty. Now, I fear, the FDA has usurped the role of the KGB,” Dr. Lewis’ open letter states.
“Now, for the first time I’m scared. The FDA panel for excimer laser approval has ‘refused to evaluate hyperopia [farsightedness] data’ until all Nidek machines are made hacker-proof. The brilliance of Nidek’s modular design frightens the FDA. They worry someone could burn EPROMs and substitute advanced software to achieve the outstanding results already enjoyed by the International Refractive Surgical community for years,” the letter by Dr. Lewis states.
It continues, saying that the FDA defines “this now crippled device as ‘substantially equivalent’ to the one I purchased.”
Dr. Lewis said that several months ago at Nidek’s request he allowed field engineers to certify his machines as compliant with the FDA protocol for safety and effectiveness. He procured affidavits detailing the modifications from the technicians.
“The FDA should not make up the rules as it goes,” the letter states.
Letter concludes by stating that “every computer scientist, programmer, and hacker knows seemingly simple changes in software and/or hardware can have unanticipated side effects. I am not letting 15 years of practice go down the drain. I am the doctor and I will do no harm. The FDA has crossed the line!”
In addition to his statements, Dr. Lewis has posted letters from Jerome D. Poland, MD, to his congressional district representative, James Oberstar, D-Minn., asking that the congressman look into the handling of the decision to lock down the devices.
Both Dr. Lewis and Dr. Poland imply in their letters that much of the hostility and focus on the Nidek machines is coming at the behest of others in the industry, because Nidek does not have per procedure fees like competitors Alcon and Visx.
For Your Information:
- James S. Lewis, MD, can be reached at 100 Old York Rd., Main Lobby, Jenkintown, PA 19046; (215) 886-9090; fax: (214) 886-1818; e-mail: jslewis@jameslewismd.com; Web site: www.ihatemyglasses.com. Jerome D. Poland, MD, can be reached at One Third Avenue, NE, Crosby, MN 56441; (218) 546-5108; fax: (218) 546-5736. Everette Beers, PhD, can be reached at (301) 594-4613; fax: (301) 480-4201. Nidek, makers of the EC-5000, can be reached at 47651 Westinghouse, Dr., Fremont, CA 94539-7474; (510) 353-7719; fax: (510) 226-5750.