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The retinal implant provides stimulation to induce visual perception in blind individuals.

Important Safety Information

Patients should always discuss the potential risks and benefits of the Argus II Retinal Prosthesis System with a physician.

Indications for Use

The Argus II Retinal Prosthesis System is intended to provide electrical stimulation of the retina to induce visual perception in blind patients. You are eligible for the Argus II system if you have severe to profound retinitis pigmentosa and you meet the following criteria:

  • You must be an adult, age 25 years or older.
  • You must have bare light or no light perception in both eyes. If you do not have any remaining light perception, your doctor will test your eye to make sure it will respond to electrical stimulation.
  • You need to have been able to see objects, shapes and lines in the past.
  • In the eye that will be implanted, you either need to have an artificial lens or no lens at all. (If the eye that will be implanted still has a natural lens, your doctor will remove this lens during the implant surgery.)
  • You must be willing and able to follow the recommended schedule of clinical follow-up, device programming and visual rehabilitation after you are implanted.

Your doctor will implant the Argus II Implant in only one of your eyes, most likely the eye that has the worse vision. Your doctor will discuss with you which eye is best for the implant before your implant surgery.

When the Device Should Not be Used (Contraindications)

You should not have the Argus II Retinal Prosthesis implanted if you:

  • Have an eye disease or condition that could prevent the Argus II System from working properly.
  • Have an eye structure or condition that could make it difficult to successfully implant the Argus II Implant or recover following surgery. For example, if you have a very long or very short eye, you may not be eligible for the Argus II Implant.
  • Have eye diseases or conditions that make it difficult for your doctor to see inside your eye. For example, if you have a cloudy cornea, you may not be eligible for the Argus II Implant.
  • Are unable to undergo general anesthesia
  • Are unable to take the recommended antibiotic and steroid medications that you need to take before and after implant surgery.
  • Have a metallic or active implantable device in your head. For example, if you have a cochlear implant, you are not eligible for an Argus II Implant.
  • Have any disease or condition that prevents you from understanding or giving your informed consent. For example, if you have difficulty remembering things, you may not be eligible for an Argus II Implant. Your doctor may ask you to have a psychological evaluation to make sure you are qualified for this device.
  • Have any disease or condition that prevents you from having medical follow-up or having the VPU programmed.
  • Tend to rub your eye a lot.

Warnings

Once you have an Argus II Implant:

  • Do not undergo short wave or microwave diathermy. These procedures could cause high electrical current in the implant electrodes that could cause tissue damage or serious injury. Diathermy may also cause permanent damage to the implant.
  • Do not undergo electroconvulsive therapy (ECT). ECT may damage your eye or your Argus II Implant.
  • Avoid lithotripsy or high output ultrasound. These procedures may harm you or damage the implant. If you need one of these procedures, inform your doctor that you have this implant. Your doctor should contact Second Sight Medical Products for instructions on how to perform these procedures in someone who has an Argus II Implant.
  • Do not enter a room housing a magnetic resonance imaging (MRI) System that has a rating other than 1.5 or 3.0 Tesla, even if you are not using Argus II System.

    The only part of the Argus II System that has been tested for use with MRI is the implant. The Argus II Implant is classified as an MR Conditional device.

    If you have an Argus II Implant, you may undergo an MRI procedure ONLY if it is performed using a 1.5 or 3.0 Tesla MRI System and ONLY following special instructions. Before having an MRI procedure, tell your doctor that you have the Argus II Implant. Your doctor should contact Second Sight Medical Products for these instructions on how to perform an MRI in someone who has an Argus II Implant.

    If you feel any pain during the MRI procedure, tell the technician immediately.
    Do not take the VPU or glasses into the MR system room. The VPU and glasses are MR Unsafe. Severe harm to people in the MR system room or damage to this equipment may result.
  • Do not use the Argus II System within 3 feet (0.9 meters) of medical monitoring, diagnostic or life support equipment. Using the Argus II system near this equipment may cause the equipmentto function improperly. If someone notices that interference is occurring, turn off the Argus II VPU or extend the distance between yourself and the equipment.
  • Do not receive treatment with monopolar electrosurgical equipment. Monopolar electrosurgical equipment may damage the implant or the tissue around the implant.

General Precautions

  • Stop using the Argus II System if you experience any uncomfortable feeling such as pain. Should this occur, immediately take off the Argus II Glasses or turn off the Argus II VPU. Then contact your doctor or programming clinician to report the problem.
  • Contact your doctor promptly if you feel any pain or watering in your implanted eye or if you have the feeling that something is in your implanted eye. This may be a sign that you have a complication on the outside or inside of your eye. If your doctor does not examine your eye when you have these symptoms, you may develop an infection in your eye or have other serious complications.
  • The long-term effects of electrical stimulation are unknown. It may cause damage to the retina or optic nerve. This sort of damage could lead to a decline in your normal remaining vision and/or how well you see with the Argus II System. It could also prevent you from getting a replacement Argus II Implant or another type of retinal implant or treatment in the future.
  • Do not use anyone else’s VPU. Only use the VPU that your clinician programmed for you. Using someone else’s VPU may limit how well you see with the Argus II System. It could also cause you pain if it provides stimulation that is too strong.
  • Avoid physical impact or extreme direct pressure to the eye. This could cause injury to your eye, movement of the implant in your eye, or damage to the implant.. If this occurs, contact your physician.
  • Avoid rubbing your implanted eye. This may dislodge the implant or cause eye irritation.
  • Do not rely on the Argus II System as your only aid when walking. The Argus II System will not provide you with enough vision to walk safely without any other aids. Even though you have the Argus II Implant, continue to use your other mobility aids (for example, canes, dogs) at all times.
  • Do not use the Argus II System during pregnancy or when nursing a baby. Second Sight has not evaluated the use of the Argus II System by women who are pregnant or who are nursing a child.

Electromagnetic Interference (EMI)

Electromagnetic interference is a field of energy (electrical, magnetic, or both) created by equipment found in public environments that may be strong enough to interfere with the normal operation of your Argus II System.

The Argus II System meets international standards for electromagnetic compatibility. The Argus II System continues to operate in a “safe mode” in the presence of any electromagnetic interference that you would encounter during your normal everyday activity.

It is important to note, however, that in certain circumstances, electromagnetic interference could cause:

  • Serious injury. Exposure of your implant to EMI may result in your implant heating and damaging nearby retinal tissue. See “Warnings” .
  • Damage to your Argus II Implant. Damage to the implant may require replacement; or result in loss of, or irreversible change in the performance of the Argus II System. See “Warnings” .
  • Unexpected shutdown of the Argus II VPU. EMI may cause your VPU to turn off unexpectedly.
  • Interruption of Stimulation. EMI may cause a momentary interruption of stimulation.

If you suspect that electronic equipment is causing interference with your Argus II System, you should do the following:

  1. Move away from the equipment or object thought to be causing the interference.
  2. If possible, turn off the equipment or object causing the interference.
  3. Tell the equipment operator or your doctor what happened.

If you continue to experience interference, or if you think that your Argus II System is not working as well as it did before you encountered the interference, please contact your doctor.

The following sections provide additional information regarding potential sources of electromagnetic interference:

  • Precautions Regarding Other Medical Procedures
  • Possible Interference from Other Electronic Devices
  • Air Travel, General Travel and International Use

Precautions Regarding Other Medical Procedures

General Information (applicable to all procedures)

  • If you need to undergo any of the procedures listed below, please inform your doctor that you have a retinal prosthesis in your eye. Your doctor should contact Second Sight at 1-818-833-5060 for more information.
  • Do not wear or use your Argus II Glasses or VPU when undergoing a medical test or procedure, unless you are having a vision test. Using or wearing the Argus II Glasses or VPU during these procedures could cause you harm. It might also make it difficult for your doctor to understand the results of the test. Finally, it could damage the Argus II equipment.
  • Once the procedure is complete, you should have your clinician test your Argus II Implant as soon as possible to make sure it is still functioning properly. Damage to the implant may not be immediately detectable.

Information about Specific Procedures

  • Magnetic Resonance Imaging (MRI) – Refer to section “Warnings” for information about MRI.
  • Avoid the use of laser, fragmatome or phacoemulsification in your implanted eye. These proceduresmay damage the Argus II Implant.
  • Avoid the use of bipolar electrosurgical equipment in your implanted eye. This equipment may damage the Argus II Implant.
  • You may undergo computed tomography scan (CT Scans) or Diagnostic Ultrasound. However, if you need a scan or ultrasound in the area where the Argus II Implant is located, the implant may block or blur the image making the scan unreadable in this area.
  • Use of defibrillators or radiation therapy to the head may permanently damage the Argus II Implant. However, this should not stop you from receiving these treatments if necessary.
  • The effects of cobalt treatmentor linear acceleration techniques on the implant are unknown.

Possible Interference from Other Electronic Devices

  • Avoid Theft or metal detectors (such as those located in entrances to public buildings and department stores) and airport or security screening devices. If unavoidable, turn off your VPU, walk through the scanner, and quickly move away from the area. Do not lean on these scanners or linger in their path. These devices may temporarily interrupt Argus II stimulation if you are using the Argus II System within 1 yard (0.9 meters) of them. Your Argus II System will start operating normally when you move away from these items. You should show your patient identification card to any attendant in the area who may be able to assist you in bypassing these devices.
  • Avoid Electronic Article Surveillance (EAS) systems, EAS Tag Deactivators, and Radiofrequency identification (RFID)systems. These systems may temporarily interrupt Argus II stimulation if you are using your Argus II System within 3.5 yards (3.2 meters) of them. Your Argus II System will start operating normally when you move away from these items. RFID systems, EAS systems and tag deactivators send out energy fields that wirelessly communicate with tags attached to objects such as merchandise, materials and people. Business uses these systems for security, theft prevention, tracking and inventory control. Retail stores, libraries, government buildings, warehouses and offices often use these systems. For example, security tags attached to clothing contain RFID tags.
  • Avoid handling the VPU and glasses if you suspect there may be static electricity present. Static electricity may interfere with normal operation or cause damage to the Argus II System. For example, walking across carpet in a low humidity environment can cause you to build up static electricity.
  • The Argus II System may interfere with the normal operation of some models of hearing aids. If you wear a hearing aid, you should have it tested with the Argus II System before implant surgery to make sure both the hearing aid and Argus II System will function properly.
  • Avoid home appliances, such as microwaves, and some devices with antennae, such as cell phones, when using the Argus II System. Home appliances and devices with antennae may temporarily interrupt Argus II stimulation.
  • Do not turn on the Argus II System on an airplane. The Argus II System operates using wireless technology that could interfere with the safe operation of an airplane.
  • Avoid commercial electrical equipment, communication equipment, high voltage lines, power lines or generators, electric steel furnaces, or large magnetized speakers. These types of equipment may temporarily interrupt Argus II System function. Normal operation should resume when you move away from these objects.
    Examples of commercial electrical equipment include arc welders, induction furnaces and resistance welders. Examples of communication equipment include microwave transmitters, linear power amplifiers and high-power amateur transmitters.

Air Travel, General Travel and International Use

CAUTION: Do not turn on the VPU or use the Argus II System on an airplane. The Argus II System operates using wireless technologies that could interfere with the safe operation of an airplane.

You may want to travel with your Argus II System. When travelling and not using the Argus II System, store the Glasses and VPU in the travel case.

If you will be traveling outside the United States, you may need an adapter to plug the VPU battery charger into the electrical outlet.

Bring your patient identification card with you to assist in going through security systems. The section below describes the patient identification card. Turn off the VPU when you go through security.

If your eye is experiencing any medical complications before your trip, speak with your doctor to determine if it is safe for you to travel, especially on a plane. You may also wish to speak with your doctor in advance of your trip to obtain the name of a local ophthalmologist in the event of any complications during your trip.

For more information about travel, contact the Transportation Security Administration (TSA):
Website: www.tsa.gov
Email:
TSA General Phone Number: 866-289-9673
TSA Cares Phone Number: 855-787-2227

TSA Cares is a toll free helpline designed to assist travelers with disabilities and medical conditions, prior to getting to the airport. You should call TSA Cares 72 ahead of traveling so that the TSA has the opportunity to coordinate checkpoint support with a TSA Customer Service Manager located at the airport when necessary.

ADVERSE EVENTS

Adverse events related to the device, therapy or surgical procedure can include:
360° Circumferential vitreous band traction, Choroidal detachment, choroidal effusion, conjunctival congestion, conjunctival cyst, conjunctival dehiscence, conjunctival erosion, conjunctivitis, corneal abrasion, corneal dryness, corneal epithelial defect, corneal filaments, corneal fold, corneal melt, corneal opacity, corneal suture broken, corneal vascularization, decrease in light perception, elective revision surgery, endophthalmitis, epiphora, epiretinal membrane, fibrosis around the tack, filamentary keratitis, foreign body sensation, headache, high intraocular pressure, hyphema, hypotony, keratic precipitates, keratitis, nausea, nystagmus increase, ocular fibrin, ocular inflammation, ocular pain, proliferative vitreoretinopathy, ptosis, re-tack, retinal detachment, retinal folds, retinal tear, retinal thickening (with or without cystic changes), Retinoschisis, Rubeosis, scleral patch displacement, Scleritis, subconjunctival eyelashes, suture irritation, uveitis, vertigo, and vitreous hemorrhage.

HUMANITARIAN DEVICE: Authorized by Federal (U.S.) law to provide electrical stimulation of the retina to induce visual perception in blind patients with severe to profound retinitis pigmentosa and bare light or no light perception in both eyes. The effectiveness of this device for this use has not been demonstrated. Rx Only: Federal law restricts this device to sale by or on the order of a physician.