FDA Medical Device Recalls (openFDA)
RVO 2.0, INC: Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
- Recall number
- Z-0865-2019
- Recalling firm
- RVO 2.0, INC
- Product
- Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
- Status
- Terminated
- Initiated
- 2018-11-13
- Posted
- 2019-03-05
- Terminated
- 2024-03-14
- Reason
- During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
- Root cause
- Unknown/Undetermined by firm
- Action
- 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.
- Quantity
- 2869
- 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, serial or model codes
- All lots of unused product
- 510(k) numbers
- not on file
- PMA numbers
- ["P150034"]
- Product code
- LQE
- Firm FEI
- 3015045165
- Firm city
- Aliso Viejo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28