FDA: Class I recall of RVO 2.0 Raindrop near vision inlay

Editor's Note

The Food & Drug Administration (FDA) on March 5 identified the recall by RVO 2.0, Inc (Aliso Viejo, California) of its Raindrop near vision inlay as Class I, the most serious.

All lots of the inlay are being recalled because data from the post-approval study showed an increased risk of corneal haze (a type of cloudiness in the cornea due to inflammation).

The inlay was designed to be surgically implanted into the cornea of one eye to improve near vision as an alternative to glasses or contact lenses.

Distribution dates were August 1, 2016 to March 7, 2018.