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Double carding extends treatment beyond FDA approval. |
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Controversial
Double carding is a controversial
and possibly illegal technique to perform refractive surgery beyond
the FDA approved parameters of the excimer lasers. All excimer lasers have limitations of treatment
imposed by the FDA. These limitations may be significantly less
than what a doctor may consider to be appropriate care.
Laser Key Card
The manner by which some
excimer lasers are controlled is with a card similar to a credit
card that the doctor purchases from the laser manufacturer. The
card allows the doctor to provide a single treatment and only within
the FDA approved parameters. If a doctor believes that treatment
beyond the FDA approved parameters is appropriate, during surgery the doctor will exchange
the first card for a second card and continue the treatment.
Let's say that you have
18.00 diopters of myopia and the laser the doctor uses is only allowed to treat
up to 12.00 diopters of myopia. The doctor will start the surgery
with card number one and do 12.00 diopters of correction. Then,
without you moving, the doctor replaces card one with card two and
performs the additional 6.00 diopters of treatment.
Legality Unclear
The legality of this technique
is unclear. The doctors who double card state that they are essentially
doing two surgeries and at worst this is an off-label use of the device. They further argue that it is better for
the patient to have both surgeries done consecutively than to have
the patient come back in a month for the second 6.00 diopters of
correction.
Patient Informed Consent
Any patient which will have a double carded treatment should be fully informed of the off-label nature of the use of the medical laser. The attempted correction has not been scrutinized
by the FDA and probable outcomes are unknown. The patient should clearly understand that double carding is not in
the spirit of the FDA limitations, may be illegal, and certainly
is questionable.
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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