Class 2 Device Recall Optical Coherence Tomography System

• Date Initiated by Firm: July 27, 2017
• Create Date: October 04, 2017
• Recall Status: Terminated on April 12, 2021
• Recall Number: Z-0010-2018
• Recall Event ID: 77776
• 510(K)Number: K133892
• Product Classification: Ophthalmoscope, ac-powered - Product Code HLI
• Product: iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and 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 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
• Code Information: Cat No. 700-49428-001 (GTIN - N/A), 700-49428-002 (GTIN 00858848006315), 700-49428-003 (GTIN 00858848006018).
• Recalling Firm/ Manufacturer: Optovue, Inc.; 2800 Bayview Dr; Fremont CA 94538-6518
• For Additional Information Contact: 866-941-9240
• Manufacturer Reason for Recall: FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
• FDA Determined Cause: Other
• Action: Optovue sent an Urgent Medical Device Software Field Correction letter dated July 27, 2017, via FedEx mail. Customers were Instructed to discontinue use of the Vault Mapping software, to complete and return the recall response form, and to provide remote access to units to an Optovue representative so that new software can be downloaded remotely. Questions can be addressed by calling Optovue at 1-866-941-9240.
• Quantity in Commerce: 326 devices
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HLI