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.
Use of the cam attachment may result in a positioning anomaly and mistreatment in the eyes of the patient.
조치
Optovue Inc. sent a Field Modification/Correction Notice dated July 20, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were informed that they could continue to use the iVue until the correction has been made. Customers were instructed to review any existing iVue patient data to ensure that this situation and an improper designation of eye assignment has not occurred. Upon completion of the updates, customers were to sign the attached form indicating they acknowledge that their iVue has been updated and they understand that they must review existing data.
For any questions regarding this recall call 1-866-344-8948 or by mail at 45531 Northport Loop W, Fremont, CA 94538.
Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured by Optovue, Fremont, CA || Computer controlled opthalmic imaging system. Device scans the patient's eye using low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface. The computer has a graphic user interface for acquiring and analyzing the image. The iVue offers three scans: Retina, Glaucoma and Cornea. For the cornea scan, a lens must be attached to the front of the device for proper scanning. This is the Cornea Anterior Module (CAM).