Download 2008-2009 Basic and Clinical Science Course: Section 13: by Christopher J. Rapuano, MD PDF
By Christopher J. Rapuano, MD
This part underwent significant revision for the 2008-2009 edition.Reviews the underlying ideas in refractive surgical procedure, together with its clinical foundation, the position of the FDA, and sufferer overview. particular methods are mentioned intimately, and using refractive surgical procedure to regard presbyopia is tested. a brand new bankruptcy discusses foreign views.
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Additional info for 2008-2009 Basic and Clinical Science Course: Section 13: Refractive Surgery
MedWatch allows health care professionals and consumers to report serious problems that they suspect are associated with the medical devices they prescribe, dispense, or use. htm, by phone (1-800- FDA-1088), or by submitting the MedWatch 3500 form by mail or fax. Voluntary reporting to the FDA is an easy, minimally timeconsuming task that has an enormous impact on public health. The FDA relies on AE reports to maintain a safety surveillance of all FDA-regulated devices. Physician reports may be the critical action that prompts a modification in the use or design of a product, improves the safety profile of a device, and leads to increased patient safety.
For example, keratoconus could be an exclusion criterion as well as a contraindication to laser in situ keratomileusis (LASIK). The clinical trial is performed for a limited range of refractive errors. Safety and effectiveness data guide the range of refractive error that is approved for use in the PMA labeling. If a treating clinician does not follow the labeling recommendations for the device, he or she is using the device "off-laber' Some off-label uses reflect the PMA's lack of data on safety and effectiveness-for example, use of the device in a patient listed within the exclusion criteria; other off-label uses reflect decreased or unknown safety or effectiveness-for example, use of the device beyond the refractive range of the labeling.