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Raindrop Near Vision Inlay Recalled

3/5/2019 FDA Recalls Raindrop Near Vision Inlay

On December 28, 2018, Allergan issued an “Urgent Drug Recall” of 22 lots of OZURDEX. The recall was prompted by the finding of a silicone particulate of 300 microns diameter in dispensed OZURDEX implants. Allergan determined that the particulate originated from the needle sleeve.

Allergen identified the following safety risks: “Mild transient visual disturbances or intraocular inflammatory reaction in sensitive patients” and “…a remote possibility of corneal reaction if the particulate migrates to the anterior chamber.” Allergan categorized the risk probability as low, based on the infrequent dosing of OZURDEX.

However, OMIC has received 1 report to date of a reaction in a bilaterally treated patient who experienced a reaction in one eye, resulting in hand motion vision. Therefore, the potential side effects should not be minimized, and patients should be counseled carefully about watching for and immediately reporting signs and symptoms.

Insureds who have lots of OZURDEX should follow Allergans’ advice regarding inspecting the lot numbers in your inventory and returning any recalled lots to Allergan, preserving evidence, and reporting adverse reactions.

OMIC risk management recommendations

  1. Follow the recommendations of the manufacturer.
  2. Disclose the recall to the affected patients (see attached sample letter to patients) and add the letter to the patient’s medical record.
  3. Monitor patients for signs and symptoms.
  4. Report adverse reaction to Allergan.
  5. Treat the symptoms.
  6. Document your discussions and treatment in the medical record.

OMIC policyholders may obtain confidential advice by contacting our Risk Management Hotline at 800-562-6642, option 4, or riskmanagement@omic.com.

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