Class 1 Recall of Raindrop Near Vision Inlay

Mar 05, 2019 at 05:59 pm by Staff


After issuing a warning last October, the FDA has now announced a Class 1 recall of Raindrop Near Vision Inlay by Optics Medical. Designed to be surgically implanted in the cornea, the FDA granted approval of the device in 2016 to ReVision Optics to improve near vision and offer an alternative to glasses or contact lenses in healthy patients. The device is now owned y RVO 2.0, dba Optics Medical. At issue is a risk of corneal hazing, which can cause blurry vision or glare.

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