Amid concerns about the risk of complications with Raindrop corneal inlay procedures, RVO 2.0 Inc. is recalling nearly 3,000 corrective vision implants, due to a risk of corneal haze and other vision problems.
A Raindrop Near Vision Inlay recall was announced by the FDA on March 5, including a warning that indicates the implant may pose a serious risk for consumers and may impair their vision.
The FDA classified the action as a class I recall, which is the most serious type of medical device recall, reserved for products that may result in serious injury or death.
The Raindrop Near Vision Inlay is a transparent, curved hydrogel disc that is smaller than the eye of a needle. It is designed to be surgically implanted into the cornea of the eye to improve near vision and offer an alternative to eyeglasses or contact lenses. The Raindrop Inlay reshapes the central region of the cornea to offer an area in the eye with increased power for focusing on near objects and improve vision overall.
RVO 2.0 indicated data from the post-approval study concludes there is an increased risk of corneal haze. Corneal haze is a type of cloudiness in the cornea caused by inflammation. The haziness can impair the vision of the consumer with the inlay.
The FDA issued a safety warning about the issue on October 23, 2018, indicating that doctors should stop using the medical device because three out of every four patients suffered from vision problems after having the inlay implanted, according to a post-marketing study.
An “Urgent Medical Device Recall” letter was sent to customers on November 13, 2018, instructing customers to stop implanting the Raindrop Inlay and return unused products.
Patients who have the inlay implanted in their eye should contact their doctor and receive an evaluation to determine how to proceed. If they experience any visual symptoms, like blurry vision or glare, they should seek an evaluation sooner.
The class I recall affects all lots of the Raindrop Near Vision Inlay model number RD1-1 distributed August 1, 2016, to March 7, 2018.
For more information about the recall or the device contact Optics Medical at (949) 330-6511. Any side effects related to the Raindrop Inlay should be reported to the FDA MedWatch Adverse Event Reporting Program immediately.