I have recently seen a cluster of patients with late complications of the Raindrop corneal inlay.
By way of history, the Raindrop corneal inlay was initially approved for sale in the United States on June 29, 2016. On Oct. 23, 2018, an FDA Safety Communication was issued for the Raindrop corneal inlay. ReVision Optics ceased commercial operations Jan. 30, 2018. My estimate of the number of Raindrop corneal inlays implanted during the period of commercial implantation is between 2,000 and 3,000.
The primary reason for the FDA communication was the (Read more...)
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