Device evidence

device-recall:cfres:143858

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.

Official recall number

Z-1245-2016

Evidence summary

Product code: HKN
Recall status: Terminated
Event initiated: February 29, 2016
Root cause: Component design/selection
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1245-2016