The US Food and Drug Administration (FDA) has upgraded a recall of the Raindrop corneal inlay to Class 1, its highest level used for devices with the potential to cause serious injuries or death.
RVO 2.0, trading as Optics Medical, which now owns the device following the original owners Revision Optic’s demise last year, is recalling Raindrop because data from the inlay’s post-approval study showed an increased risk of corneal haze.
For more, see www.eyeonoptics.com.au/articles/archive/fda-warns-against-raindrop-inlay.
