Rinsada® Treatment Consent Form

Eye irritation can cause eye discomfort and blurred vision. Healthy eyes make a tear film that protects the eyes. The tear film has a water layer, a mucus layer, and an oily layer. Sometimes, irritants can be trapped on the ocular surface or water layer. This eye irritation can result in discomfort.

Rinsada® is a medical device that treats eye irritation. Your eye doctor will put numbing drops into your eyes to make your eyes more comfortable. The eye doctor will then place the device underneath your eyelid. The device rinses the undersurface of the eyelid as well as the eyeball. This helps remove debris and irritants on the eye surface.

The goal of a Rinsada® treatment is to make your eye more comfortable. Your eye may not feel better the first few days. Your eye may not feel completely better if you have some diseases, have had symptoms a long time, or have an eye gland disease. The treatment can help for up to 3 months. You may need to have a treatment again. Talk to your eye doctor about how well Rinsada® will work for you and how often you will need a treatment.

It is your choice to have a Rinsada® treatment. Here are some other options.

• Eye irritation can damage the surface of the eye if it is not treated, but your eyes may not bother you enough to have treatment.

• There are other treatments such as eyelid scrub with warm compresses, eye drops, punctal plugs that keep tears in the eye, or or surgery to open the tear ducts.
  
  

As with all surgery, there are risks (problems that can happen) with Rinsada®. While the eye doctor cannot tell you about all risks, here are some of the most common or serious:

• Eye injury

• Eye infection

• Eye or eyelid pain

• Eyelid irritation (redness, burning, tearing, itching, discharge, foreign body sensation)

• Changes in your vision

• Sensitivity to light

• Scratch on the front of the eye

• Swelling of the lining of the eye
  
  

Consent. By signing below, you consent (agree) that:

• You read this informed consent form, or someone read it to you.

• You understand the information in this informed consent form.

• The eye doctor or staff offered you a copy of this informed consent form.

• The eye doctor or staff answered all your questions about Rinsada®.