Raindrop Near Vision Inlay — Class I medical device recall Z-0865-2019
Terminated recall by RVO 2.0, INC, reported 2019-03-13, distributed in AL, AR, AZ, CA, CO, FL, GA, HI…. During a post approval study the firm found there was an increased risk of corneal haze following the implanta
| Recall number | Z-0865-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RVO 2.0, INC, Aliso Viejo, CA, United States |
| Recall initiated | 2018-11-13 |
| Classified | 2019-03-05 |
| Reported by FDA | 2019-03-13 |
| Terminated | 2024-03-14 |
| Distributed | 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 |
| Quantity | 2,869 |
| Model numbers | RD1-1 |
Product
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0865-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.