The Ministry of Food and Drug Safety ordered a recall of “Raindrop Near Vision Inlay” due to reports of corneal haze caused by inflammation in patients who received the inlay treatment to correct near vision.
The ministry said it found the U.S. Food and Drug Administration’s updated safety information on the risky medical device and notified the recall to the Korean Hospital Association, the Korea Medical Association, and the Korean Ophthalmological Society.
On Oct. 23, the FDA requested physicians to stop using the Raindrop Near Vision Inlay, citing corneal haze in patients who underwent the implant procedure with the product.
The FDA said it was cooperating with Optics Medical, the manufacturer of the device, to recall all of the products. The Raindrop Near Vision Inlay is not available anymore in the U.S.
According to the FDA, patients who have received the inlay transplant removed the device due to corneal opacities. One patient had the first haze six months after removing the device. Some others continued to complain of corneal haze even after the removal.
In Korea, HKT imports and distributes Raindrop Inlay.
The ministry ordered hospitals to discontinue using the product and separately keep it. It also instructed patients who had the inlay procedure to promptly visit a hospital to check if corneal opacity has developed.