Are IOLs approved by the Food and Drug Administration (FDA) USA?

Are IOLs approved by the Food and Drug Administration (FDA) USA?

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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