Crystalens AO Lens is an artificial lens implant that can treat both a person's cataracts and presbyopia —the clouding or hardening of your lenses, and the loss of near and intermediate vision, respectively. Crystalens was modeled after the human eye. Like the natural lens, it is a lens implant that uses the eye muscle to flex and accommodate in order to focus on objects in the environment at all distances. Crystalens dynamically adjusts to your visual needs. Many patients will have greater freedom from glasses after surgery, but you may still need reading glasses for small print or other near vision tasks.

Crystalens AO is implanted during one of the most commonly performed surgeries in the world. Over 3 million cataract surgeries are performed in the US every year. 

Key Features & Benefits

  • The first FDA-approved accommodating intraocular lens - meaning that it uses the natural focusing ability of the eye
  • Crystalens AO was inspired by the eye’s natural crystalline lens.
  • Unlike multifocal lenses, Crystalens AO directs all available light received by the eye to a single focal point, so that you can focus on objects at all distances.
crystalens angled

An Important Choice

During cataract surgery, your physician will replace your natural lens with an IOL. Today there are multiple types of IOLs, each delivering a different performance profile based on how the lens is designed. Ask your doctor about standard monofocal IOLs, multifocal IOLs, and Crystalens accommodating IOLs to see which is right for you.

  • Standard monofocal IOLs deliver improved vision at just one distance, usually far.
  • Multifocal IOLs are designed to deliver improved vision for distance and near. However, some patients may experience some halos and glare when driving at night, and some patients have difficulty adjusting to their new vision.
  • Crystalens IOLs are designed to reduce your need for prescription glasses during your normal daily activities. Crystalens has flexible hinges that enable it to move and flex with your eye, in response to the eye's focusing muscle. Its movement is similar to the eye's natural lens.

INDICATIONS

Crystalens accommodating posterior chamber intraocular lens (IOL) is for use in patients to improve uncorrected near, intermediate and far (distance) vision after cataract removal.

IMPORTANT SAFETY INFORMATION: Your eye doctor will advise you about the potential risks and benefits of cataract removal and IOL implantation.

  • Tell your eye doctor if you have been diagnosed with any eye disease. The safety and effectiveness of Crystalens has not been established in patients with preexisting eye conditions and complications during surgery, such as an increase in eye pressure or complications of diabetes in the eye. The outcome of cataract surgery will depend on the health of your eye before surgery.
  • Tell your eye doctor if you have had prior refractive surgery, such as LASIK. The safety and effectiveness of Crystalens has not been studied in patients with prior refractive surgery.
  • You will need to wear glasses if you have nearsightedness, farsightedness, or uncorrected astigmatism after surgery, and will be likely to need to wear reading glasses if you must do prolonged reading or read small print.
  • Complications of cataract surgery range from minor, usually temporary side effects, to sight-threatening complications. These complications are extremely rare and include, but are not limited to: infection, hemorrhage, and retinal detachment.
  • Significant sight-threatening complications are extremely rare and include, but are not limited to: infection, hemorrhage, and retinal detachment. People with existing medical conditions such as diabetes and chronic eye infections are at a higher risk of developing complications. If the Crystalens IOL moves and the hinges get stuck (called vaulting), this usually causes blurry vision. If your vision becomes blurred, contact your eye doctor immediately. You may need additional surgery to reposition or replace the IOL, or to treat other surgery complications.
  • The effectiveness of ultraviolet light absorbing lenses in reducing the incidence of retinal disorders has not been established. Therefore, you should wear sunglasses with UV 400 protection when in sunlight.
  • The long term safety and effectiveness of this lens have not been proven.

This is not all you need to know. Please see the FDA Patient Information Brochure for additional information and discuss any questions with your eye doctor.


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Condition(s)

CRS.0078.USA.16

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