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Terminated

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

FDA Recall Z-1441-2013 · Posted 2013-05-31

Recalling FirmOptovue, Inc.
Recall StatusTerminated
Product CodeHLI
Date Initiated2013-05-14
Date Terminated2013-10-24
Product Quantity~329 users

Reason for Recall

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.

Firm Action

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.

Root Cause

Software design

Distribution Pattern

Distributed Nationwide and in Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121739IVUE WITH NORMATIVE DATABASEOptovue, Inc. · 2013-01-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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