Medical DeviceSep 6, 2017
Optovue iFusion, Device Listing Number D203271 recall — FDA Z-0009-2018
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Class IIFDA: TerminatedOptovue, Inc.
Recall history in this database
Classification mix: Class II: 4.
Medical DeviceSep 6, 2017
Optovue iVue with Normative Database, Device Listing Number D185549 recall — FDA Z-0008-2018
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Class IIFDA: TerminatedOptovue, Inc.
Medical DeviceSep 6, 2017
Optovue iVue 500 with iScan, D216606 recall — FDA Z-0010-2018
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Class IIFDA: TerminatedOptovue, Inc.
Medical DeviceApr 27, 2016
Optovue iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 recall — FDA Z-1498-2016
A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database that may display images of the same eye rather than right and left if user scrolls on the map.
Class IIFDA: TerminatedOptovue, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Optovue, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.