Recall Z-1853-2014 ยท HKN Refractor, Manual, Non-Powered, Including Phoropter
Nidek Inc
RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan. Instrument provides means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject's eyes for purpose of determining refractive error and binocular functions.
| Date | Jun 23, 2014 (initiated Jun 9, 2014) |
| Status | Terminated |
| Reason | Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury. |
| Root cause | Use error |
| Action | Recall/Field Correction letters were sent to doctors on June 9, 2014 with a preventive maintenance instruction to be performed on the device by user. Also included are the necessary tools to perform actions. Customers are to complete and return the Recall Response Card. Questions are to be directed to Customer Service. Contact Information: Customer Service: 1-800-891-1772 E-mail: RT-5100 update@noritsu.com |
| Quantity | ~4,285 units RT-5100; 167 units of RT-3100 |
| Distribution | US distribution only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.