A recall of the Raindrop near vision inlay has been issued by RVO 2.0 due to an increased risk of corneal haze, according to an FDA notice.
RVO 2.0, which is doing business as Optics Medical, owns the device, which was approved in 2016 and originally brought to market by the now-defunct ReVision Optics.
A safety communication from the FDA issued in October 2018 recommended the Raindrop inlay stop being implanted after a post-approval study found 75% of patients experienced corneal haze.
The Class I recall affects all lots of (Read more...)
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