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U.S. Department of Health and Human Services

Class 2 Device Recall Optical Coherence Tomography System

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  Class 2 Device Recall Optical Coherence Tomography System see related information
Date Initiated by Firm July 27, 2017
Create Date October 04, 2017
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = OPTOVUE, INC.
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