Drug recall
Raindrop Near Vision Inlay, Model# RD1-1
FDA recall event 76422 · Class II · Revision Optics Inc
Key facts
| Event ID | 76422 |
|---|---|
| Recall numbers | Z-1518-2017 |
| Recalling firm | Revision Optics Inc |
| Product type | Devices |
| Products | Raindrop Near Vision Inlay, Model# RD1-1 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | ReVision Optics has updated the instructions for use (IFU) for the Raindrop Near Vision Inlay to emphasize that only Balanced Salt Solution (BSS) may be used to irrigate under the flap and that… |
| Initiation date | Feb 7, 2017 |
| Report date | Mar 29, 2017 |
| Termination date | Jun 21, 2017 |
| City | Lake Forest |
| State | CA |
| Country | United States |
| FEI number | 3005956347 |
At a glance
- 1–9 Products in this recall
- 1–9 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: