Reported Jul 2, 2014 · Terminated
RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan.…
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 Refractor and RT-3100 Refractor
- Distributed by MARCO OpthalmicManufactured 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
- Lot codes and dates
- RT-5100 and RT-3100, various serial numbers.
- Amount recalled
- ~4,285 units RT-5100; 167 units of RT-3100
Why it was recalled
Near Point Chart Arm of RT 5100 and RT-3100 Refractors may lower spontaneously with potential for patient injury.
This product could cause temporary or reversible health problems — stop using it.
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