Drug recall
OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02…
FDA recall event 71691 · Class II · Nidek Inc
Key facts
| Event ID | 71691 |
|---|---|
| Recall numbers | Z-2477-2015 |
| Recalling firm | Nidek Inc |
| Product type | Devices |
| Products | OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Software bug was found where there was no difference in Total and Corneal high-order aberrations, but differences were found in Internal high-order aberrations. |
| Initiation date | Jun 15, 2015 |
| Report date | Sep 2, 2015 |
| Termination date | Apr 25, 2016 |
| City | Fremont |
| State | CA |
| Country | United States |
| FEI number | 2936921 |
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: