UPDATED TO FDA CLASS 1 DEVICE RECALL: Raindrop Near Vision Inlay may raise risk of corneal haze

The FDA has issued a Class 1 Device Recall on the Raindrop Near Vision Inlay, effective March 5.

Last fall, the agency advised eye care providers to stop implanting Raindrop inlays due to an increased risk of postoperative corneal haze. The clear hydrogel disc is indicated for patients with emmetropic presbyopia. In an October 23 alert, the agency announced it was working with the manufacturer Optics Medical to recall all remaining inlays from the market. The device, approved in 2016, is no longer distributed in the United States.

The decision stems from a post-approval study of 150 patients who were followed for 5 years after implantation. During this period, corneal haze developed in 75% of patients and affected the central cornea in 42% of patients. “The impact of haze on the patient’s vision is dependent on the severity of haze and its location in the cornea," the FDA said.

Steroid drops resolved the haze in some cases, but were ineffective in others. To date, 23.3% of patients have had the device removed and some continue to experience corneal haze even after removal. The study is ongoing and patients will continue to be monitored.

Patients with existing inlays should be closely monitored for corneal haze, the agency said. Healthcare professionals should contact Optics Medical (949-330-6511) to receive instructions for returning unused inlays. Physicians and patients can report adverse reactions to the FDA through the MedWatch Adverse Event Reporting site or by mail or fax (1-800-FDA-0178).