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IMPORTANT SAFETY INFORMATION
Approved use: The IC-8 Apthera intraocular lens (IOL) is approved for adult patients who need surgery to treat cataract, have corneal astigmatism (up to 1.5 diopters) before surgery, and do not have preexisting retinal conditions.
Who should not receive this treatment? The IC-8 Apthera IOL is contraindicated for patients whose pupils do not dilate widely and patients with any retinal disease or for patients who may be at risk for getting retinal diseases in the future.
What warnings should I be aware of? Your eye doctor will determine if you are a candidate for the IC-8 Apthera IOL. Preexisting retinal disease and certain eye conditions may increase the risk of complications. If you have any complications during your cataract surgery before the IC-8 Apthera IOL is implanted, you may need to have another IOL implanted instead of the IC-8 Apthera IOL.
What precautions should I be aware of? The safety and effectiveness of the IC-8 Apthera IOL have not been established in patients with certain preexisting eye conditions or in patients who experience certain complications during cataract surgery. You should discuss these possible conditions with your eye doctor to determine if you are a candidate for the IC-8 Apthera IOL.
What are the potential risks? As with any surgical procedure, there are risks associated with cataract surgery and implantation of an IOL that you and your eye doctor should discuss. Potential risks associated with the IC-8 Apthera IOL include unwanted visual effects such as glare, appearance of rings around lights, starburst, faded colors, blurry or double vision, and trouble seeing at night. Following implantation of the IC-8 Apthera IOL, your eye doctor may need to perform additional procedures to give you the best vision outcome possible. There is a small chance that you may require additional surgery as a result of a complication.
Attention: Reference the Patient Information Brochure for each IOL for a complete listing of warnings and precautions.
Caution: Federal law restricts this device to sale by or on the order of a physician.
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