Drug recall
RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd…
FDA recall event 68485 · Class II · Nidek Inc
Key facts
| Event ID | 68485 |
|---|---|
| Recall numbers | Z-1853-2014 |
| Recalling firm | Nidek Inc |
| Product type | Devices |
| Products | RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan. Instrument provides means of positioning spherical and cylindrical lenses… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury. |
| Initiation date | Jun 9, 2014 |
| Report date | Jul 2, 2014 |
| Termination date | Oct 30, 2015 |
| 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: