Description

The Simedice Family of Lenses are artificial lenses implanted in the eye of adult patients following cataract surgery. The Simedice IOLs are designed to allow for clear distance vision. However, you will likely still need glasses for reading and for distance vision particularly if you already have astigmatism. The Simedice Toric IOLs are also designed to correct pre-existing corneal astigmatism, which is the inability of the eye to focus clearly at any distance because of difference curvatures on the cornea, and provide distance vision.

Warnings / Precautions

You may experience and need to contact your eye doctor immediately if you have any of the following symptoms after cataract surgery: itching, redness, watering of your eye. The safety and effectiveness of these IOLs have not been established in patients with eye conditions, such as an increase in eye pressure (glaucoma) or complications of diabetes in the eye (diabetic retinopathy). As with any surgical procedure, there are risks involved. These risks may include but are not limited to infection, damage to cornea, retinal detachment, inflammation or swelling inside or outside the eye, damage to the iris, or an increase in eye pressure. There is a possibility that the IOL may be placed incorrectly or could move within the eye. This may result in less improvement or a reduction in vision, or it may cause visual symptoms. The Simedice Toric IOLs correct astigmatism only when placed in the correct position in the eye. There is a possibility that these Toric IOLs could be placed incorrectly or could move within the eye. This may result in less improvement or a reduction in vision because your astigmatism has not been fully corrected, or it may cause visual symptoms.

Expected lifetime of the device

The Simedice Family of Lenses is non-absorbable implants, the expected lifetime of the device is usually last a lifetime.

Overall qualitative and quantitative information on the materials and substances to which patients can be exposed

The materials and substances to which the patient can be exposed is Acrylate / Methacrylate Copolymer with Ultraviolet Filtering include PEA, PEMA, BDDA and UV-13, the total quantity is less than 100ug/g, which is far less than the human tolerable intake.

Attention to ensure safe use of the device by the patient

 As with any surgical procedure, there are risks involved. Prior to surgery, discuss any questions about possible risks and benefits associated with your eye doctor.