FDA-Device2014-07-02Class II
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.
Nidek Inc
Hazard
Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.
Sold states
US distribution only.
Affected count
~4,285 units RT-5100; 167 units of RT-3100
Manufactured in
47651 Westinghouse Dr, N/A, Fremont, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1853-2014Don't want to check this manually?
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