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iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolu...

FDA Device Recall #Z-0009-2018 — Class II — July 27, 2017

Recall Summary

Recall Number Z-0009-2018
Classification Class II — Moderate risk
Date Initiated July 27, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Optovue, Inc.
Location Fremont, CA
Product Type Devices
Quantity 326 devices

Product Description

iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND iVue with Normative Database (K121739) - The iVue is a noncontact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior. ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects.

Reason for Recall

FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).

Distribution Pattern

US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, & WV.

Lot / Code Information

Cat No. 700-49001-001 (GTIN - N/A), 700-49001-003 (GTIN - N/A), 700-49001-004 (GTIN 00858848006186).

Other Recalls from Optovue, Inc.

Recall # Classification Product Date
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
Z-1441-2013 Class III Optovue iVue with Normative Database (NDB) with... May 14, 2013

Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

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.

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