Drug recall
Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc.
FDA recall event 81812 · Class I · RVO 2.0, INC
Key facts
| Event ID | 81812 |
|---|---|
| Recall numbers | Z-0865-2019 |
| Recalling firm | RVO 2.0, INC |
| Product type | Devices |
| Products | Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc. |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Nov 13, 2018 |
| Report date | Mar 13, 2019 |
| Termination date | Mar 14, 2024 |
| City | Aliso Viejo |
| State | CA |
| Country | United States |
| FEI number | 3015045165 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: