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
Refractor, manual, non-powered, including phoropter - Product Code HKN
원인
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.
조치
Nidek sent a Recall letters dated February 29, 2016 to all affected site. The letter identified the affected product, problem and actions to be taken. Nidek Customer Service will be replacing the affected product with new parts to address this recall. For questions call Customer Service at 1-800-722-0219.
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.