Nidek Inc recalls RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical…

Recall date

February 29, 2016

Source

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

Recall number

Z-1245-2016

FDA classification

Class II

Brand / firm

Nidek Inc

Sold / distributed

US Nationwide Distribution

Why it was recalled

There has been a reoccurrence of an issue on the RT 5100 and RT 3100 Refractor of the Near Point Chart Arm lowering spontaneously with potential for slight injury to face or nose of patient.

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

What was recalled

RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions.