Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
This recall has been terminated (originally issued March 5, 2019).
- Company
- Rvo 2.0, Inc
- Recall Initiated
- November 13, 2018
- Posted
- March 5, 2019
- Terminated
- March 14, 2024
- Recall Number
- Z-0865-2019
- Quantity
- 2869
- Firm Location
- Aliso Viejo, CA
- Official Source
- View on FDA website ↗
Reason for Recall
During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
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.
Lot / Code Info
All lots of unused product
Root Cause
Unknown/Undetermined by firm
Action Taken
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 Jennifer.Luong@opticsmedical.com. Customers with questions are encouraged to call 949-330-6511.