Device product
RT-5100 Refractor, a component of the Epic-5100 System.
Z-0655-2019
Product summary
- Firm
- Nidek Inc.
- Event
- Event 81529
- Status
- Terminated
- Classification
- Class III
- Quantity
- 85 instruments
- Official record key
device-enforcement:Z-0655-2019
Official wording
Reason: The lens bonding was incomplete on the refractor.
Code information: 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
Distribution pattern: Distribution was made to FL.
Derived failure modes
-
Unknown
The lens bonding was incomplete on the refractor.