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# RVO 2.0 Recalls Raindrop Vision Inlay
- URL: https://www.fdaweb.com/rvo-2-0-recalls-raindrop-vision-inlay/
- Published: 2019-03-05T12:00:00.000Z
- Updated: 2026-09-15T01:10:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143522

RVO 2.0 has [recalled](https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm632670.htm?ref=fdaweb.com) its Raindrop Near Vision Inlay because data from a post-approval study showed an increased risk of corneal haze (a type of cloudiness in the cornea due to inflammation) associated with the device. The device is now owned by RVO 2.0, doing business as Optics Medical.

The transparent, curved hydrogel disc was designed to be surgically placed into the cornea of one eye to improve near vision and offer an alternative to eyeglasses or contact lenses in healthy patients. The device is intended to reshape the central region of the cornea to provide a zone of increased power for focusing on near objects, resulting in improvement in near vision.

Late last year, FDA issued a [safety communication](https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm623973.htm?ref=fdaweb.com) about the corneal haze issue. The agency is recommending that patients should not receive the device.