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POTENTIAL RISKS: There are risks associated with cataract surgery. The complications and side effects experienced during the clinical study were similar to those experienced with other intraocular lenses and with routine cataract surgery. Because it is surgery it is not completely risk-free. Complications may occur as a result of the removal of your cataract whether or not an intraocular lens is implanted. Complications of cataract surgery range from minor, usually temporary side effects, to sight-threatening complications. Fortunately, 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. You may have reactions to medicines, and side effects include redness, scratchiness of the eye, and sensitivity to light. Possible complications from cataract surgery include infection, bleeding, inflammation, tissue damage, tissue swelling of the front or back of the eye, or an increase in eye pressure. If your lens is not in the correct position, your vision may also be affected and the normal flow of fluid within the eye may be blocked. Your vision may not improve or may get worse if these complications occur. You may require additional surgery to treat these side effects.


INDICATIONS FOR USE: Crystalens® AO IOL is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia. Crystalens® AO IOL provides approximately one diopter of monocular accommodation which allows for near, intermediate, and distance vision without spectacles. Warnings: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient. Some adverse events which have been associated with the implantation of intraocular lenses are: hypopyon, intraocular infection, acute corneal decompensation, and secondary surgical intervention. Precautions: Do not resterilize; do not store over 45°C.
ATTENTION: Refer to the Physician Labeling for complete prescribing information

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SUR/CRS/15/0029