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
Ophthalmoscope, ac-powered - Product Code HLI
원인
Colors from the ndb comparison for ganglion cell complex thickness in the singular ou report in ivue version 3.0 (us) and 3.1(international) are different from those in the individual iwellness id and os reports.
조치
Optovue sent a Field Correction Notice letter dated May 16, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.