Drug recall
Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version…
FDA recall event 70672 · Class II · Optimedica Corporation
Key facts
| Event ID | 70672 |
|---|---|
| Recall numbers | Z-1683-2015 |
| Recalling firm | Optimedica Corporation |
| Product type | Devices |
| Products | Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both eyes have the same parameters. |
| Initiation date | Feb 20, 2015 |
| Report date | Jun 3, 2015 |
| Termination date | Dec 8, 2015 |
| City | Sunnyvale |
| State | CA |
| Country | United States |
| FEI number | 3005675890 |
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: