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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, Bladeless Lasik, PRK, LASEK, Epi-Lasik and similar refractive laser eye surgery procedures beyond the parameters
determined by the US Food and Drug Administration (FDA) to be safe and effective.
Unapproved Alterations
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.
USAEyes Investigagion
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, Bladeless 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
Affected Lasers
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.
Safety Locks
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.
Halt Use
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 other excimer lasers or other lasers manufactured by Nidek.
Safe Doctors
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.
Looking For Best Lasik Surgeon?
If you are ready to choose a doctor to be evaluated for conventional
or custom wavefront Lasik, Bladeless Lasik, PRK, or any refractive surgery procedure, we recommend you consider a doctor who has been evaluated and certified by the USAEyes nonprofit organization.
Locate a USAEyes Evaluated & Certified Lasik Doctor.
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