FDA Device recall Z-0865-2019
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc
- FDA Device
- Class I
- terminated
- Published 2019-03-13
On 2019-03-13 the FDA classified a Class I recall of Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc by Rvo 2 0, citing during a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0865-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-11-13 |
| Published | 2019-03-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Rvo 2 0 |
| Distribution | AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI |
Product
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
Reason
During a post approval study the firm found there was an increased risk of corneal haze following the implantation of this device.
Identifiers
| code_info | All lots of unused product |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0865-2019%22
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