Reported Apr 8, 2015 · Terminated

YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment of intraocular diseases for…

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?

  • YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment of intraocular diseases for outpatients by mechanical disruption caused by energy of the YAG laser pulses.
Lot codes and dates
  • Serial numbers

    856 of 856 codes

    • 80007
    • 80008
    • 80009
    • 80010
    • 80011
    • 80012
    • 80013
    • 80014
    • 80015
    • 80016
    • 80017
    • 80018
    • 80019
    • 80020
    • 80021
    • 80042
    • 80043
    • 80044
    • 80045
    • 80046
    • 80047
    • 80048
    • 80049
    • 80050
    • 80051
    • 80052
    • 80053
    • 80054
    • 80055
    • 80056
    • 80077
    • 80078
    • 80079
    • 80080
    • 80081
    • 80082
    • 80083
    • 80084
    • 80085
    • 80086
    • 80087
    • 80088
    • 80089
    • 80090
    • 80091
    • 80113
    • 80114
    • 80115
    • 80116
    • 80117
    • 80118
    • 80119
    • 80120
    • 80121
    • 80122
    • 80123
    • 80124
    • 80125
    • 80129
    • 80154
Amount recalled
799 units

Where it was sold

  • Nationwide

Why it was recalled

Dear Doctor letter and Quick Reference Guide is being sent to users of the YC-1800 to reiterate important safety and cleaning information after complaints of pitting lens that may cause unclear images.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 3, 2015 · Data as of Sep 19, 6:14 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.