The FDA issued a Class 1 recall (the most serious type of recall) due to a post-approval surveillance study that showed 75% of Raindrop inlay patients developed corneal hazing.
What is the Raindrop?
It’s a corneal inlay placed in the corneal stroma for correction of presbyopia.
What if I have a patient with this inlay?
The FDA is advising 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. (via)
