Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only… recallZ-0865-2019 · Rvo 2.0, Inc · initiated Nov 13, 2018
Class I Terminated All recalls posted in March 2019
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Rvo 2.0, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
FDA root cause category: Unknown/Undetermined by firm
What the company is doing
On 11/13/2018, the firm started emailing Urgent Medical Device Recall notices and acknowledgment forms to consignees. This recall notice was intended for 1) patients implanted with the Raindrop Inlay and 2) eye care providers. Eye care providers were asked to cease further implantation and to return unused affected devices to the recalling firm. Eye care providers were informed that patients implanted with affected devices should continue to see their eye care providers on a regular basis, preferably every 6-months and no less often than every 12 months. Also, patients who have had their devices explanted should maintain a follow-up schedule with their provider. The firm commits to physicians to support the patient's best interests and to continue the FDA post approval study to monitor the device's ongoing performance and safety. The firm requests that all consignees complete and return, acknowledgement forms, regardless of whether they do or do not have unused affected product to return. Acknowledgement forms should be returned via email to [email protected]. Customers with questions are encouraged to call 949-330-6511.
Recall details
- Recall number
- Z-0865-2019
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Nov 13, 2018
- Posted by the FDA
- Mar 5, 2019
- Recalling firm
- Rvo 2.0, Inc
- Quantity
- 2869
- Product code
- LQE
- FDA submissions
- P150034
- Distribution
- U.S.: NV, GA, NY, MN, TX, ND, AZ, VA, SD, IN, MA, MO, CA, NC, UT, IL, NH, OH, OK, FL, NJ, TN, MI, PA, HI, ID, KY, NE, AL, LA, CO, MD, MS, OR, WI, AR, WA; No OUS (Foreign) Distribution.
Product description
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
Code information (models, lots, serial numbers)
All lots of unused product
Other devices under the same FDA submission
1 device cleared under P150034 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Raindrop Near Vision Inlay RD1-1Revision Optics, Inc. · Implant, Corneal, Refractive154 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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