A Class I recall of the Raindrop near vision inlay has been issued due to an increased risk of corneal haze, according to the FDA.
The owner of the Raindrop inlay, RVO 2.0, doing business as Optics Medical, issued the recall after an October warning letter from the FDA cited a post-approval surveillance study that showed 75% of Raindrop inlay patients developed corneal hazing.
“The recall includes 2,869 units of the device and is being done because data from a new study showed a higher risk to patients of corneal haze, an inflammation of the cornea that causes cloudiness in a person’s vision,” according to the FDA notice.
All lots of unused product are being recalled. The product was distributed between August 1, 2016, and March 7, 2018. The model number is RD1-1. The notice is a Class I recall, the most serious type of recall, indicating that use of the device “may cause serious injuries or death.”
The FDA is recommending that patients with the device implanted seek evaluation soon if they have or develop any new or bothersome visual symptoms such as blurry vision or glare.
The FDA advised eye care providers not to implant Raindrop inlays, and to contact Optics Medical (949-330-6511) for instructions on returning any unused product to the firm. It also advised providers to monitor patients with the implant for the development of corneal haze, and to monitor patients whose device has been explanted for the development of corneal haze.
In February 2018, ReVision Optics, the maker of the Raindrop Near Vision Inlay, confirmed to Eyewire News that it was ceasing its operations.
The FDA approved the Raindrop in 2016. The FDA’s approval was supported by a prospective, non-randomized clinical study in patients who had the device implanted. At the time of device approval, the 2-year clinical study results showed that 16.1 % (60 of 373) of patients had central corneal haze of any severity at some point during follow-up. The percentage of patients with 2 or more lines of loss in vision on the eye chart caused by corneal haze was 1.1 % (4 of 373 patients). The number of patients who had the device removed was 24 of 373 patients (6.4%) at the 2-year follow-up visit, and 29% of device removals (7 of 24 patients) at this time point were due to corneal haze.