Class I Recall of RVO 2.0 Raindrop Near Vision Inlay
RVO 2.0 is recalling the Raindrop Near Vision Inlay because data from the post-approval study showed an increased risk of corneal haze associated with the device. The device is now owned by RVO 2.0, doing business as Optics Medical. The FDA has classified this as a Class I Recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
On October 23, 2018, the FDA issued a Safety Communication about this issue with the Raindrop Inlay and have updated it to include this recall notice. The Raindrop Near Vision Inlay is a transparent, curved hydrogel disc smaller than the eye of a needle. The device was designed to be implanted into the cornea of one eye improve near vision and offer an alternative to eyeglasses or contact lenses in healthy patients. The Raindrop Inlay reshapes the central region of the cornea to provide a zone of increased power for focusing on near objects, resulting in improvement in near vision.
Recalled Product Information:
- Raindrop Near Vision Inlay
- Lot Number: All lots of Unused product
- Model Number: RD1-1
- Distribution Dates: August 1, 2016, to March 7, 2018.
- Devices Recalled in the U.S.: 2,869 units
On November 13, 2018, Optics Medical sent customers an "Urgent Medical Device Recall" letter. Optics Medical sent a follow-up letter on November 18, 2018, to customers who did not respond. Both letters instructed customers to:
- Immediately stop implanting the Raindrop Inlay in patients.
- Return any unused Raindrop Inlays to Optics Medical c/o the UPS Store at 26895 Aliso Creek Road # B -1049, Aliso Viejo CA 92656.
- Complete and return the Raindrop Near Vision Inlay – Acknowledgement Form attached with the firm's recall letter even if you do not have any unused Raindrop Inlay devices.
The FDA is recommending that patients should not receive the Raindrop Near Vision Inlay device. The FDA also recommends that patients be encouraged to keep their regularly scheduled appointments with thier eye care provider. Patients should seek sooner evaluation if any new or bothersome visual symptoms such as blurry vision or glare develop. Eye care providers will determine appropriate treatment options based on the results of an evaluation.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
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