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Recall Observatory FDA recall evidence

Device product

Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.

Z-1441-2013

May 14, 2013

Class III

Product summary

Firm
Optovue, Inc.
Event
Event 65191
Status
Terminated
Classification
Class III
Quantity
~329 users
Official record key
device-enforcement:Z-1441-2013

Official wording

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.

Code information: 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.

Distribution pattern: Distributed Nationwide and in Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.