||May 31, 2013
||Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1.
Intended for in vivo imaging.
||iVue software version 3.0 and 3.1
3.1 is international version, only distributed to Canada but not currently installed in any Canadian facilities.
2800 Bayview Dr
Fremont, California 94538-6518
|For Additional Information Contact
510-623-8868 Ext. 102
|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.
||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.
|Quantity in Commerce
||Distributed Nationwide and in Canada.