Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in ...
FDA Device Recall #Z-1441-2013 — Class III — May 14, 2013
Recall Summary
| Recall Number | Z-1441-2013 |
| Classification | Class III — Low risk |
| Date Initiated | May 14, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Optovue, Inc. |
| Location | Fremont, CA |
| Product Type | Devices |
| Quantity | ~329 users |
Product Description
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
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.
Distribution Pattern
Distributed Nationwide and in Canada.
Lot / 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.
Other Recalls from Optovue, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0009-2018 | Class II | iFusion, Device Listing Number D203271. Prod... | Jul 27, 2017 |
| Z-0008-2018 | Class II | iVue with Normative Database, Device Listing Nu... | Jul 27, 2017 |
| Z-0010-2018 | Class II | iVue 500 with iScan, D216606. Product non-c... | Jul 27, 2017 |
| Z-1498-2016 | Class II | iVue and iVue 500 (now called iScan) OCT system... | Mar 16, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.