Reported Dec 26, 2018 · Terminated
RT-5100 Refractor, a component of the Epic-5100 System.
Nidek Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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 Refractora component of the Epic-5100 System
- Lot codes and dates
85 of 85 codes
Serial numbers 921042921043921044921045921046921047921048921049921050921051921052921053921054921055921056921057921058921059921060921061921062921063921064921065921066921067921068921069921070921071921072921073921074921075921076921077921078921079921080921081921084921085921086921087921088921089921090921091921092921093921094921095921096921097921098921099921100921101921102921103
- Amount recalled
- 85 instruments
Where it was sold
Why it was recalled
The lens bonding was incomplete on the refractor.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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