Recall Z-0655-2019
Nidek Inc. · initiated June 14, 2018
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
RT-5100 Refractor, a component of the Epic-5100 System.
Codes / lots: 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
Reason for recall
The lens bonding was incomplete on the refractor.
FDA-determined cause: Employee error
Action taken
The recalling firm called the sole distributor on 6/14/2018 to determine the quantity of instruments still in their control. During the phone call, the distributor was also notified of the invoice numbers that show the serial numbers involved, was asked to segregate the affected product, and a schedule was discussed for the recalling firm's technicians to visit the distributor for correction of the product.
Details
- Recall number
- Z-0655-2019
- Initiated
- June 14, 2018
- Terminated
- June 3, 2020
- Product code
- HKN – Refractor, Manual, Non-Powered, Including Phoropter
- Quantity
- 85 instruments
- Distribution
- Distribution was made to FL.
- Recalling firm
- Nidek Inc., Fremont, CA