FDA has upgraded a recall of the Raindrop corneal inlay to Class I, the most serious designation.
Developed by the now-defunct ReVision Optics, the inlay was designed to treat presbyopia. But 75% of patients in a post-approval surveillance study developed corneal hazing. ReVision closed its doors last year; RVO 2.0, doing business as Optics Medical, now owns the Raindrop device and initiated the recall in November, advising customers not to implant the inlay devices. Raindrop is banned from distribution in the U.S., according to FDA.
Lake Forest, Calif.-based ReVision won pre-market approval from the FDA in June 2016 for the Raindrop inlay to treat presbyopia. The device is a microscopic hydrogel inlay placed in the cornea of the patient’s non-dominant eye during a 10-minute procedure to reshape the anterior curvature of the cornea.
The recall covers 2,869 devices distributed between August 2016 and March 2018. FDA issued a safety communication in October, citing a five-year, 150-patient post-approval study. Interim data showed a 42% rate of central corneal haze (63/150), a 75% rate of any corneal haze (113/150) and a 23.3% rate of device removal to date (35/150); of those, some 31% (11/35) had their Raindrop implant removed due to corneal haze, according to the agency.
FDA had initially cleared Raindrop based on two-year clinical data showing a 16.1% rate of central corneal haze (60 of 373 patients), a 1.1% rate of patients with two or more lines of loss in vision (4/373) and a device removal rate of 6.4% (24/373); some 29% of those removals were due to corneal haze (7/24), the agency said.
FDA said it began working with Optics Medical last year to remove the product from the market.
