Nidek Inc. recalls AUTO REF/KERATOMETER ARK-1s

Recall date

December 20, 2017

Source

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

Recall number

Z-1348-2018

FDA classification

Class II

Brand / firm

Nidek Inc.

Sold / distributed

Distributed domestically to AK, AL, AR, CA, CO, DE, FL, GA, ID, IL, IN, MD, MI, MO, MT, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WV.

Why it was recalled

There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.

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

What was recalled

AUTO REF/KERATOMETER ARK-1s