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How FDA Dropped Patient Warning Rule from LASIK Approvals

Two years before rising complaints erupted in public from LASIK patients with post-surgical vision problems, FDA’s Center for Devices and Radiological Health, on its own initiative, quietly removed a LASIK laser condition of approval that “[p]rospective patients, as soon as they express an interest in LASIK and prior to undergoing surgery, must receive from the treatment provider the Patient Information Booklet.”… “Why are patients’ rights more protected when they pop a pill than when they undergo an irreversible elective surgery on their eyes?” …

Read more: How FDA Dropped Patient Warning Rule from LASIK Approvals

Categories: FDA, Uncategorized

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