RT-5100 Refractor — Class III medical device recall Z-0655-2019
Terminated recall by Nidek Inc., reported 2018-12-26, distributed in FL. The lens bonding was incomplete on the refractor.
| Recall number | Z-0655-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nidek Inc., Fremont, CA, United States |
| Recall initiated | 2018-06-14 |
| Classified | 2018-12-20 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2020-06-03 |
| Distributed | FL |
| Quantity | 85 instruments |
| Serial numbers | 150028, 150029, 150030, 150031, 150032, 150033, 150034, 150035, 150036, 150037, 150038, 150039, 150040, 150041, 150042, 150043, 150044, 150045, 150046, 150047, 150048, 150049, 150050, 150051, 150052 and 60 more |
Product
RT-5100 Refractor, a component of the Epic-5100 System.
Reason for recall
The lens bonding was incomplete on the refractor.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0655-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.