FDA-Device2016-03-30Class II
RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions.
Nidek Inc
Hazard
There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point Chart Arm lowering spontaneously with potential for slight injury to face or nose of patient.
Sold states
US Nationwide Distribution
Affected count
2703 separate serial numbers
Manufactured in
47651 Westinghouse Dr, N/A, Fremont, CA, United States
Products
RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1245-2016Don't want to check this manually?
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