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FDA Issues Class I Recall of Raindrop Near Vision Inlay Device

RVO 2.0 (doing business as Optics Medical) is recalling the Raindrop Near Vision Inlay device based on data from a postapproval study showing an increased risk for corneal haze (a type of cloudiness in the cornea due to inflammation) associated with the device.

This is being categorized by the US Food and Drug Administration (FDA) as a Class I recall, the most serious type of recall, because of the risk for serious injury or death.

The Raindrop device is a transparent, curved hydrogel disc tinier than the eye of a needle that is surgically implanted into the cornea of one eye. It was designed to improve near vision and offer an alternative to eyeglasses or contact lenses in healthy patients.

The FDA approved the device in 2016.

Last year, the FDA issued an alert about increased risk for corneal haze with the Raindrop device after 75% of patients in a postapproval study of the device developed corneal haze.

All lots of unused product are being recalled. The product was distributed between August 1, 2016, and March 7, 2018. The model number is RD1-1. The recall covers 2869 devices.

Optics Medical has sent customers an “urgent medical device recall” letter instructing customers to immediately stop implanting the Raindrop Inlay in patients and return all unused product to Optics Medical c/o the UPS Store at 26895 Aliso Creek Road # B-1049, Aliso Viejo, CA 92656.

The FDA is recommending that patients with the device implanted seek evaluation soon if they have or develop any new or bothersome visual symptoms such as blurry vision or glare.

Customers with questions related to this recall should call Optics Medical at (949) 330-6511 Pacific Standard Time.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA‘s MedWatch Safety Information and Adverse Event Reporting Program.

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