What is Patient Information Booklet?

The Patient Information Booklet provides data from FDA clinical trials including risks, contraindications, warnings and results. The FDA requires that every patient who is about to undergo LASIK surgery be given the Patient Information Booklet published by the laser manufacturer. Non-compliance with this FDA mandate is widespread. Each FDA-approved laser has an approval order with the Patient Information Booklet mandate. Lasik Doctors hide booklets from patients and 99,99% of patients don't receive those before lasik. In this blog you will see a compilation with tables from Patient Information Booklets. They all are available on the fda web page. This is the most official information about lasik. If patients were receiving Patient Information Booklets before surgery, most wouldn't do lasik. Patient Information Booklets show a high number of 'symptoms' (Dry eyes, halos, starbusts, light sensitivity, glare, double vision.....), that's the main reason why lasik doctors hide booklets from patients. LASIK manufacturers and their collaborators successfully pressured FDA to classify these problems as mere “symptoms” so that manufacturers could claim that the adverse event rate is less than one percent.

Below are three examples of the FDA mandate regarding Patient Information Booklets. The first example is found in an FDA Approval Order for the VISX laser, the second is found in the VISX Physician Instruction Booklet and third is found in an FDA premarket approval laser.
"Prospective patients, as soon as they express an interest in wavefront-guided LASIK for myopic astigmatism and prior to undergoing surgery, must receive from the treatment provider the Patient Information Booklet (as described in your final submission to this PMA supplement)." Link
"All patients must be given the opportunity to read and understand the Patient Information Booklet and to have all their questions answered to their satisfaction before giving consent for Laser Assisted In Keratomileusis (LASIK). " Link
 "In advance of surgery, all prospective patients must receive the Patient Information Booklet (as described in your final submission to this PMA) from their treatment providers.Link

Example of an FDA Patient Information Booklet Cover from the laser Alcon Ladar6000.