The LASIK industry & the FDA have conspired since LASIK's inception to purposely withhold information vital to the public in making a truly informed LASIK decision. With Lasikdecision.com, The hope is to show you what the industry and FDA would not and did not even think of doing until LASIK casualties started speaking out, and yet, they still did NOTHING.
ASF FDA Medwatch Reporting Ignored or Unknown PDF Print E-mail

ALL LASIK ASF’s (Ambulatory Surgical Facilities) were supposed to have been reporting  ALL PATIENT ADVERSE EVENTS (Complications, Side Effects, Patient Dissatisfactions, and Symptoms) to the FDA’s internal MEDWATCH database, but have not been doing so since 1997 (since LASIK)…

Below is a recent deposition of a LASIK surgeon who testified as a defense expert in a LASIK malpractice lawsuit.  This is a perfect example of how LASIK surgeons completely ignore MedWatch reporting requirements:

SOURCE

page 74 - 76

Q. What role does the FDA play in refractive surgery?

A.  I don't know the specifics of exactly what the FDA's role is but they are responsible for making sure that the devices that we invent work well and they set up parameters for how to use those devices.

Q. Do you know what an adverse incident report is?

A. I have a general understanding of that.

Q. What is your general understanding?

A.  My general understanding is that if something happens that is significant and negative and unexpected.

Q. Something significant, negative and unexpected happens. What is the doctor's obligation or the lasik surgeons obligation?

MR. STOTT: Object to the form.

THE WITNESS: I don't know what you mean.

BY MR. BURNS:

Q. Do you have to tell the FDA?

I don't know what those rules are. I don't know.

Q. Have you ever notified the FDA of any adverse incident involving lasik surgery?

A. I'm not sure. The administrative side handles that. It's by our admin staff.

Q. Who in your administration notifies the FDA if you have an adverse incident?

A. I don't know.

Q. Up to this moment had you any suspicion that you were to suppose to notify the FDA of an adverse incident?

MR. STOTT: Object to the form.

THE WITNESS: I was aware that we do have to report certain things.

BY MR. BURNS: Q. What things do you understand that you have to report to the FDA?

A. I don't know the details of what has to be reported to the FDA.

Q. Who have you assigned that responsibility to within the Woolfson Eye Institute?

A. I can find out who that is. We have someone in charge of operations and the admin side of that would be handled on that end.

Q. You don't know whose job that is, if anybody, at Woolfson Eye Institute?

A. I don't know who is responsible for reporting that to the FDA.

Q. Do you have something set up?

A. I believe we have something set up.

Q. Who set it up?

A. As I said it's set up on the admin side.

Q. Who set it up?

A. I don't handle the admin side.

Q. So you don't know who set it up?

A. I don't know who set up exactly what on the -- administrative side.

Q. Is it your understanding that the adverse admin report should have been filed in connection with Kelly Leo's case?

A. Again, I don't know the exact details of what need to be reported to the FDA or not.