Drug recall
OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial…
FDA recall event 80849 · Class II · Johnson & Johnson Surgical Vision Inc
Key facts
| Event ID | 80849 |
|---|---|
| Recall numbers | Z-0066-2019 |
| Recalling firm | Johnson & Johnson Surgical Vision Inc |
| Product type | Devices |
| Products | OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on the treatment… |
| Initiation date | May 9, 2018 |
| Report date | Oct 10, 2018 |
| Termination date | Jan 13, 2021 |
| City | Milpitas |
| State | CA |
| Country | United States |
| FEI number | 3006695864 |
At a glance
- 1–9 Products in this recall
- 10–99 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: