Device recall
Z-1853-2014: RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic…
FDA device recall · Class II · Nidek Inc
Key facts
| Recall number (Z-number) | Z-1853-2014 |
|---|---|
| Recall event | 68485 |
| Product | 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, prisms and other optical devices in front of a subject's eyes for purpose of determining refractive error… |
| Product code | HKN |
| Recalling firm | Nidek Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 30, 2015 |
| FEI number | 2936921 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database