Device product
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.
Z-1853-2014
Product summary
- Firm
- Nidek Inc
- Event
- Event 68485
- Status
- Terminated
- Classification
- Class II
- Quantity
- ~4,285 units RT-5100; 167 units of RT-3100
- Official record key
device-enforcement:Z-1853-2014
Official wording
Reason: Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.
Code information: RT-5100 and RT-3100, various serial numbers.
Distribution pattern: US distribution only.
Derived failure modes
-
Unknown
Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.