IOLs are approved by the FDA for implantation for those eighteen years and older. Use of an IOL under age eighteen years is off-label. Drugs and devices are often used off-label when a physician determines that use is in the best interest of a patient. The placement an IOL in a child’s eye is made after a thorough eye examination followed by a discussion with the parent/guardian about the risks and benefits of an IOL versus a contact lens or glasses (informed consent).
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Are IOLs approved by the Food and Drug Administration (FDA) USA?
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