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

Recall date

March 6, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1367-2015

FDA classification

Class II

Brand / firm

Nidek Inc

Sold / distributed

Nationwide Distribution.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.