FDA Device recall Z-0655-2019
RT-5100 Refractor, a component of the Epic-5100 System
- FDA Device
- Class III
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class III recall of RT-5100 Refractor, a component of the Epic-5100 System by Nidek, citing the lens bonding was incomplete on the refractor.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0655-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-06-14 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Nidek |
| Distribution | FL |
Product
RT-5100 Refractor, a component of the Epic-5100 System.
Reason
The lens bonding was incomplete on the refractor.
Identifiers
| code_info | Serial numbers 921042, 921043, 921044, 921045, 921046, 921047, 921048, 921049, 921050, 921051, 921052, 921053, 921054,…Serial numbers 921042, 921043, 921044, 921045, 921046, 921047, 921048, 921049, 921050, 921051, 921052, 921053, 921054, 921055, 921056, 921057, 921058, 921059, 921060, 921061, 921062, 921063, 921064, 921065, 921066, 921067, 921068, 921069, 921070, 921071, 921072, 921073, 921074, 921075, 921076, 921077, 921078, 921079, 921080, 921081, 921084, 921085, 921086, 921087, 921088, 921089, 921090, 921091, 921092, 921093, 921094, 921095, 921096, 921097, 921098, 921099, 921100, 921101, 921102, 921103, 150028, 150029, 150030, 150031, 150032, 150033, 150034, 150035, 150036, 150037, 150038, 150039, 150040, 150041, 150042, 150043, 150044, 150045, 150046, 150047, 150048, 150049, 150050, 150051, and 150052 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Device · Class II · 2017-03-29 · Nidek - SPECULAR MICROSCOPE CEM-530
FDA Device · Class II · 2016-09-07 · Nidek - OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier
FDA Device · Class II · 2016-08-24 · Nidek
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0655-2019%22
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