The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- 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
- Date Initiated by Firm: November 13, 2018
The Raindrop Near Vision Inlay is a transparent, curved hydrogel disc smaller than the eye of a needle. The device was designed to be surgically placed (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.
Reason for Recall
RVO 2.0 is recalling the Raindrop Near Vision Inlay because data from the 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.
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 information.
Who May be Affected
- Eye care providers who use the Raindrop Near Vision Inlay
- Patients who had the Raindrop Near Vision Inlay implanted
What to Do
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.
Patients who have the Raindrop Inlay Implant
- The FDA is recommending that patients should not receive the Raindrop Near Vision Inlay device.
- Be sure to keep your regularly scheduled appointments with your eye care provider. You should seek sooner evaluation if you have or develop any new or bothersome visual symptoms such as blurry vision or glare. Your eye care provider will determine appropriate treatment options based on the results of an evaluation.
Customers who have any questions related to this recall should call Optics Medical at (949) 330-6511 Pacific Standard Time.
How do I report a problem?
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. Health care professionals employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.