RT-5100 Refractor, a component of the Epic-5100 System.
This recall has been terminated (originally issued June 14, 2018).
- Company
- Nidek Inc
- Recall Initiated
- June 14, 2018
- Terminated
- June 3, 2020
- Recall Number
- Z-0655-2019
- Quantity
- 85 instruments
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The lens bonding was incomplete on the refractor.
Distribution
Distribution was made to FL.
Lot / Code Info
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
Root 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.