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Subspecialties Cornea / Ocular Surface, Health Economics and Policy, Refractive

Ticking Timebombs

As some of you may know, the original maker of the Raindrop corneal inlay, Revision Optics (RVO), abruptly closed its doors on January 30, 2018. On October 22, 2018, the US Food and Drug Administration issued an FDA Safety Communication – a recall of the Raindrop corneal inlay (1). This FDA recall followed the FDA’s premarket approval of the Raindrop corneal inlay on June 29, 2016 (2).

Figure 1. Impending corneal melt with the four areas of cornea liquefaction change visible.
Figure 2. An eye after corneal melt with inlay extrusion showing the 4+ peripheral edge haze, circular area of absent central Bowman’s layer after melt, and the dense central epithelial plug in the central crater left after the melt with inlay extrusion.

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About the Author

Harvey Carter

Refractive and cataract surgery specialist at Carter Eye Center, Dallas, Texas, USA.

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