Retisert

Preparing for Your RETISERT® Surgery

DURING SURGERY

The procedure used to implant RETISERT® is performed in an outpatient setting. This means that you will usually be able to go home the same day and you will not have to be hospitalized.

Local anesthesia will usually be used to numb your eye instead of general anesthesia.

AFTER SURGERY

A decrease in vision should be expected for approximately 1 to 4 weeks after surgery before there is improvement.

Your doctor will want to monitor your progress, examine your eyes, and look for improvements or any changes in the condition of the eye with the implant.

The Importance of Following Up After Your RETISERT® Surgery

Follow-up visits are essential to help ensure positive results post-surgery. Your doctor needs to check for any changes in the condition of the eye with the implant. Even if you are feeling fine or vision has improved dramatically, it is still necessary for you to see your doctor for follow-up care.

Follow-up visits: Year 1

Every 2 to 3 months

Follow-up visits: Year 1-2

Every 3 to 4 months

Your doctor will check for:

  • Inflammation
  • Cataract formation
  • High eye pressure (IOP)
  • Gains or losses in vision

In addition to having your vision checked, it is very important that you be monitored for increases in eye pressure. For example, if your eye pressure is high, your doctor can prescribe eye drops to lower the pressure.

SAMPLE LETTER OF MEDICAL NECESSITY

Indication

RETISERT® (fluocinolone acetonide intravitreal implant) 0.59 mg is used to treat an inflammation in the back of the eye that is not caused by an infection, called chronic non-infectious uveitis.

Important Safety Information

  • RETISERT® (fluocinolone acetonide intravitreal implant) 0.59 mg should not be used if you have an infection of the eye from viruses, bacteria, fungi or fungal diseases.
  • After receiving the RETISERT® implant, you should periodically see an eye doctor for follow-up examinations of both eyes.
  • As with any surgical procedure, there is risk involved. Complications can include injury to the eye; infection; mechanical complication, movement or ejection of the implant; and wound complications following the surgery.
  • After receiving the RETISERT® implant, nearly all patients will experience an immediate and temporary decrease in vision in the implanted eye that lasts for approximately 1 to 4 weeks following the surgery.
  • Based on clinical studies, within 3 years after receiving the RETISERT® implant, approximately 77% of patients require medications to lower pressure in the eye, and approximately 37% of patients will require a surgical procedure to control pressure in the eye.
  • Long-term use of corticosteroids may result in an increased risk of glaucoma (high pressure in the eye).
  • Based on clinical studies, within 3 years after receiving the RETISERT® implant, nearly all patients who have not already had cataracts will develop them and require surgery.
  • The most common side effects, occurring in 50-90% of patients, were cataract, increased pressure in the eye, surgery complications and eye pain. Headache was also reported in 33% of patients.

You are encouraged to report side effects to the FDA. To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb at 1‑800‑321‑4576 or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

Please click here for full Prescribing Information for RETISERT®.

Indication and Important Safety Information