Class III — Nidek Inc.
| Recalling firm | NIDEK CO., LTD. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | The lens bonding was incomplete on the refractor. |
| Product | RT-5100 Refractor, a component of the Epic-5100 System. |
| Quantity | 85 instruments |
| Distribution | Distribution was made to FL. |
| Initiated | 2018-06-14 |
| Classified | 2018-12-20 |
| Terminated | 2020-06-03 |
| Recall number | Z-0655-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Nidek Inc. (Z-0655-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81529/
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