USAEyes Consumer Alert Imported Altered and Counterfeit Lasers For Lasik

An investigation by USAEyes has affirmed that an undetermined number of US doctors (apparently less than 10) have circumvented safety restrictions by hiring third-party vendors to fundamentally alter their excimer lasers to perform Lasik, All-Laser Lasik, PRK, LASEK, Epi-Lasik and similar refractive laser eye surgery procedures beyond the parameters determined by the United States Food and Drug Administration (FDA) to be safe and effective. These alterations are not approved by the FDA, nor are they sanctioned by manufacturers. It is estimated that approximately 5,000-10,000 patients have surgery with an altered laser each year, however USAEyes has found no evidence that indicates patients have been physically harmed specifically due to the use of an altered laser.

A doctor who alters or causes to be altered a medical device so it performs outside the FDA approved parameters is circumventing processes and regulations designed to assure the highest level of safety and efficacy for Americans seeking medical care. Fundamentally altering a medical device to make it perform in a manner it is not approved to perform is not the off-label use of an approved device, which is medically appropriate

These doctors are circumventing the FDA by:

• Purchasing a laser outside of the US and having it installed in their US clinics and medical offices. These lasers are defined as ‘inappropriately imported’.
• Purchasing the laser manufacturer’s non-US software and/or hardware components and installing them on a US version of the laser to alter the US laser’s capabilities. These lasers are defined as ‘inappropriately altered’.
• Purchasing hardware and/or software manufactured by third parties not affiliated with the laser manufacturer and installing these third-party components on a US version of the laser to alter the US laser’s capabilities. These lasers are defined as ‘counterfeit’. The accuracy and safety of imported, altered, or counterfeit medical devices used for laser eye surgery is unknown, untested, and unproven to the standards required in the US

All medical devices are subject to the malfeasance of unscrupulous individuals, however the Nidek EC-5000 excimer laser seems to be a current target for import, alteration, or counterfeit. The Nidek laser distributed outside the United States has the ability to correct hyperopia, and astigmatism; such ability being approved by the respective countries. The US version of the Nidek laser does not have the ability to correct these refractive errors. By importing, altering, or counterfeiting the laser, US doctors are able to force the laser to perform these types of corrections. Unlike other laser manufacturers, Nidek does not charge a royalty fee for each use of their laser. Every time a doctor uses a Nidek laser on a patient that would otherwise require a laser that charges a royalty fee, the cost for the doctor to provide surgery to the patient is reduced by $200-$500.

In early 2002 an aggressive program to install hardware and software safety blocks was initiated by the manufacturer to stop the inappropriate use of imported, altered, or counterfeit Nidek lasers; however some doctors refused to accept these safety devices. Nidek notified the FDA, in writing, of approximately two dozen doctors who may operate with imported, altered, or counterfeit lasers and requested the FDA respond. USAEyes requested a copy of this letter under the Freedom of Information Act. Reportedly, eight to ten lasers used by the doctors named in this letter are now out of service or restored to US FDA approved standards. Other doctors, however, continue to use their imported, altered, or counterfeit lasers despite communications expressing concern from the FDA, the manufacturer, and USAEyes.

Several months ago USAEyes approached laser manufacturers and the FDA in an attempt to hasten a resolution to this dilemma and create public awareness. USAEyes has been working independently, but parallel, to halt the inappropriate use of imported, altered, and counterfeit lasers on US patients. USAEyes representatives have discussed our concerns directly with some doctors who are reportedly using suspect lasers, however it appears that the combined efforts of manufacturers, the FDA, and USAEyes have failed to totally halt the use of imported, altered, or counterfeit of lasers

The specifics of this USAEyes Consumer Alert are in regard only to early models of the Nidek EC-5000 and do not relate to excimer lasers manufactured by Alcon (LADARVision, CustomCornea), Bausch & Lomb (Technolas, Zyoptix), WaveLight (Allegretto), LaserSight (LaserScan LSX), Visx / AMO (CustomVue), or any medical device used for any other type of refractive surgery.

Doctors certified by USAEyes use only Nidek lasers approved by the FDA and maintained to FDA standards. A patient who is proposed to have surgery by a doctor not certified by USAEyes should use due diligence to determine the nature of the laser to be used, and/or should contact laser manufacturer's customer service department.

The American Academy of Ophthalmology has issued a revised policy statement condemning the use of unapproved lasers.

Update: A class action lawsuit has been filed in California regarding these concerns. See Nidek Counterfeit Laser Lawsuit.

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