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.
FDA Recall Z-1367-2015 · Posted 2015-04-02
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Recalling FirmNidek Inc
Recall StatusTerminated
Product CodeLXS
Date Initiated2015-03-06
Date Terminated2015-09-03
Product Quantity799 units
Reason for Recall
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.
Firm Action
Dear Doctor letters were sent along with a Quick Reference guide to all affected sites in February.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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