Altered and Counterfeit LASIK Laser Use Exposed

"An investigation by USAEyes.org has affirmed that an undetermined
number of US surgeons (apparently less than 10) have circumvented
safety restrictions by hiring third-party vendors to fundamentally
alter their excimer lasers to perform LASIK, IntraLASIK, 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.org has found no
evidence that indicates patients have been physically harmed
specifically due to the use of an altered laser."

http://www.usaeyes.org/counterfeit_lasik_lasers.htm

Glenn Hagele
Executive Director
USAEyes.org

"Consider and Choose With Confidence"

Email to glenn dot hagele at usaeyes dot org

http://www.USAEyes.org
http://www.ComplicatedEyes.org

I am not a doctor.

OK, I'll bite.

In the PRK, pre-LASIK days, any non-approved laser was considered a
"black box," and confiscated. I presume this falls into the same
category.

However, one should note that the FDA has neither the charter nor the
funding to guarantee that the way the laser is used is ultimately safe,
even within the specified parameters.

For example, prescribing aspirin for a headache that was caused by an
intracranial hematoma is malpractice, even though aspirin is an FDA OTC
product.

I'm not sure what law is broken if a surgeon puts a 6.5mm ablation zone
on a -9 diopter eye with an 8.5mm pupil with an FDA-approved laser.
Even though most patients do not complain to their surgeons, I think a
whole lot of harm is being done to the visual welfare of the public by
creating permanently highly aberrated eyes as a general practice.

But, I agree that strict enforcement of the law is paramount in this
business, and I applaud CRSQA for taking the lead on this issue. The
next step would be to go where the FDA fears to tread.

DrG

Black box lasers are a little different than this. A black box laser
is a laser that had never sought approval from the FDA, nor was it
manufactured by a respectable company that had received FDA approval
for similar devices. In this case, these lasers are either imported
from where they are approved, or they are US lasers that have been
altered.

Off-label use is when a device approved for one procedure is used for
another, and is medically appropriate. This is NOT off-label use.
The moment that these lasers are imported or altered, they are no
longer an approved device. Because they are not an approved device,
they cannot have an on-label use, therefore they cannot have an
off-label use.

Funding restraints notwithstanding, it is the FDA's responsibility to
police the use of inappropriately altered excimer lasers. Hopefully
our efforts to give this greater attention will put a fire under their
bureaucratic tails.

Glenn Hagele
Executive Director
USAEyes.org

"Consider and Choose With Confidence"

Email to glenn dot hagele at usaeyes dot org

http://www.USAEyes.org
http://www.ComplicatedEyes.org

I am not a doctor.