Recall Z-0655-2019 ยท HKN Refractor, Manual, Non-Powered, Including Phoropter
Nidek Inc.
RT-5100 Refractor, a component of the Epic-5100 System.
| Date | Jun 14, 2018 |
| Status | Terminated |
| Reason | The lens bonding was incomplete on the refractor. |
| Root cause | Employee error |
| Action | 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. |
| Quantity | 85 instruments |
| Distribution | Distribution was made to FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.