Company: American Optisurgical.
Date of Enforcement Report: 6/12/2013
ClassL Ill:
PRODUCT
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging. Recall Number Z-1441-2013
REASON
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.
RECALLING FIRM/MANUFACTURER
Optovue, Inc. Fremont, CA on 5/142013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
~329 users
DISTRIBUTION
Nationwide and Canada
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