FDA Questions Lasik Informed Consent, Industry Says ‘Step Off’

Recently, the FDA published a draft guidance revealing concerns that some patients are not receiving or understanding information on the benefits and risks of these devices before undergoing procedures. Issued in July for comment, the guidance states that the administration has become aware of more potential adverse effects of Lasik treatment and recommended manufacturers update their labeling so that physicians and surgeons can discuss those risks and alternative treatments with patients. These