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 Refractor
    • a component of the Epic-5100 System
Lot codes and dates
  • 85 of 85 codes

    • Serial numbers 921042
    • 921043
    • 921044
    • 921045
    • 921046
    • 921047
    • 921048
    • 921049
    • 921050
    • 921051
    • 921052
    • 921053
    • 921054
    • 921055
    • 921056
    • 921057
    • 921058
    • 921059
    • 921060
    • 921061
    • 921062
    • 921063
    • 921064
    • 921065
    • 921066
    • 921067
    • 921068
    • 921069
    • 921070
    • 921071
    • 921072
    • 921073
    • 921074
    • 921075
    • 921076
    • 921077
    • 921078
    • 921079
    • 921080
    • 921081
    • 921084
    • 921085
    • 921086
    • 921087
    • 921088
    • 921089
    • 921090
    • 921091
    • 921092
    • 921093
    • 921094
    • 921095
    • 921096
    • 921097
    • 921098
    • 921099
    • 921100
    • 921101
    • 921102
    • 921103
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 3, 2020 · Data as of Sep 19, 5:34 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.