U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Refractometer, ophthalmic - Product Code HKO
원인
Software bug was found where there was no difference in total and corneal high-order aberrations, but differences were found in internal high-order aberrations.
조치
Dear Doctor letters mailing started on July 15, 2015 - first 100. They will be mailed out as the correction is received from Nidek, Japan.
Dear Doctor letter will include software upgrade kit including CD or USB, instruction for upgrade and pre-paid response card to be returned to Nidek Inc.
OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic || Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. || Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use for Mapping of refractive error distribution of the eye by measurement and analysis of spherical power, cylindrical power, and cylinder axis.