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
800078000880009800108001180012800138001480015800168001780018800198002080021800428004380044800458004680047800488004980050800518005280053800548005580056800778007880079800808008180082800838008480085800868008780088800898009080091801138011480115801168011780118801198012080121801228012380124801258012980154
- Serial numbers
- 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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