Risk Management

2019 March Alert: RainDrop Near Vision

March 2019 Risk Management ALERT

FDA Recalls RAINDROP Near Vision Inlay

The FDA issued a Safety Alert about the Raindrop Near Vision Inlay on October 23, 2018. On March 5, 2019, the FDA recalled the device and updated the Safety Alert (https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm623973.htm), which states:

“People who undergo implantation of the Raindrop Near Vision Inlay device are at risk for the development of corneal haze that can affect clear vision. Haze can cause blurry vision or glare by clouding the cornea, or by changing the focusing power of the eye. The impact of haze on the patient’s vision is dependent on the severity of haze and its location in the cornea.”

The FDA made the following recommendations:

• Do not implant Raindrop inlays.
• Contact Optics Medical (Phone: 949-330-6511) for instructions on returning any unused product to the firm.
• Be aware of the new data from the ongoing post-approval study, which is showing 1) high rates of corneal haze in both implanted and explanted patients, 2) an increasing rate of device removal, and 3) that some cases of haze did not develop until 60 months post-implant.
• Monitor patients with the implant, and those whose device has been explanted, for the development of corneal haze.

Risk management recommendations

OMIC recommends that you take the following steps to promote patient safety and reduce your liability exposure:

• PATIENTS ALREADY NOTIFED OF THE SAFETY ALERT AND EVALUATED
  • Update patients when they present for their next appointment.
  • Share your current findings, and explain your plan for monitoring the eye.
  • Educate them about symptoms that should be reported to you.
  • Document the discussion.
• PATIENTS WHO WERE NOT NOTIFIED OR EVALUATED
  • Notify patients via a letter sent regular mail, and ask them to call your office to make an appointment (available at https://www.omic.com/fda-recalls-raindrop-near-vision-inlay/).
  • Place a copy of the letter in the patient’s medical record, and send a copy to the referring ophthalmologist or optometrist.
  • When you do examine the patient, determine if there are any signs of corneal haze or other problems.
  • Share your findings with the patient, and explain your plan for monitoring the eye.
  • Educate them about symptoms that should be reported to you.
  • Document the findings and discussion.