Reported Mar 30, 2016 · Terminated
RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical…
Nidek Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nidek Inc · 47651 Westinghouse Dr · Fremont, CA · 94539-7474
Is this the product you have?
- RT-5100 (Epic 5100)
- Refractor and RT 3100 RefractorProduct
- UsageInstrument 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
- Lot codes and dates
- serial numbersSee attached distribution list. 128 RT -3100 and 2565 RT-5100
- Amount recalled
- 2703 separate serial numbers
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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