Z-0655-2019 Class III Terminated
FDA device recall Z-0655-2019 was initiated by Nidek Inc. on June 14, 2018 and is designated Class III. Reason for recall: The lens bonding was incomplete on the refractor. The recall status is terminated (terminated June 3, 2020). Affected quantity: 85 instruments.
Recall Details
- Product Type
- Devices
- Report Date
- December 26, 2018
- Initiation Date
- June 14, 2018
- Termination Date
- June 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 85 instruments
Product Description
RT-5100 Refractor, a component of the Epic-5100 System.
Reason for Recall
The lens bonding was incomplete on the refractor.
Distribution Pattern
Distribution was made to FL.
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