Patient Information Booklet (Patient Labeling)

The Patient Information Booklet (also known as "patient labeling") provides data from FDA clinical trials including risks, contraindications, and warnings. 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. Most patients are not given a Patient Information Booklet by their surgeon. If you are considering LASIK, demand a copy of this booklet.

Click here to read a sample of the FDA mandate to provide patients with the booklet (page 2): "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." Each FDA-approved laser has an approval order with the Patient Information Booklet mandate.

Patient Information Booklets ("patient labeling") are available on the FDA website. To locate a Patient Information Booklet, click the following link: FDA approved lasers for LASIK. Then click the link for "Labeling" under the right-hand column.  

Note to personal injury attorneys: The Patient Information Booklet is the device equivalent to the package insert supplied with a prescription drug. Don't overlook the significance and importance of this document. Use this document in your client's case in the same way you would use the package insert for a prescription drug.