{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "157860", "product_res_number": "Z-0010-2018", "event_date_initiated": "2017-07-27", "event_date_created": "2017-10-04", "recall_status": "Terminated", "event_date_terminated": "2021-04-12", "res_event_number": "77776", "product_code": "HLI", "k_numbers": [ "K133892" ], "product_description": "iVue 500 with iScan, D216606.\n\nProduct 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,\ndocumentation, and management of ocular health and diseases in the adult population.", "code_info": "Cat No. 700-49428-001 (GTIN - N/A), 700-49428-002 (GTIN 00858848006315), 700-49428-003 (GTIN 00858848006018).", "firm_fei_number": "3005950902", "recalling_firm": "Optovue, Inc.", "address_1": "2800 Bayview Dr", "city": "Fremont", "state": "CA", "postal_code": "94538-6518", "additional_info_contact": "866-941-9240", "reason_for_recall": "FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).", "root_cause_description": "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.", "product_quantity": "326 devices", "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.", "openfda": { "k_number": [ "K844054", "K930023", "K871268", "K133758", "K943956", "K123316", "K912891", "K120238", "K841767", "K882517", "K950461", "K844971", "K941705", "K914484", "K843099", "K133892", "K843597", "K900111", "K003376", "K141638", "K841761", "K895010", "K100861", "K033123", "K923742", "K854244", "K942713", "K042001", "K061674", "K841764", "K983999", "K060822", "K841763", "K851263", "K994340", "K851262", "K153080", "K063343", "K772214", "K912581", "K120057", "K942712", "K981640", "K942714", "K101505", "K103266", "K131939", "K942104", "K992606", "K942720", "K912397", "K913118", "K822104", "K935988", "K063378", "K843596", "K150722", "K893173", "K951210", "K791510", "K881984", "K770768", "K843812", "K951728", "K961171", "K851264", "K951132", "K111531", "K000731", "K964137", "K951338", "K051789", "K121739", "K943955", "K041290", "K921163", "K971671", "K942711", "K142953", "K031312", "K042885", "K944261", "K110205", "K893172", "K030433", "K942715", "K843304" ], "registration_number": [ "3013403214", "2918630", "3013188547", "2132111", "3012494290", "3043126966", "3012421607", "3013298431", "3001124136", "3033882233", "2521877", "3010227033", "3005744933", "3027667933", "1316463", "3004026651", "3013436538", "1226587", "9617167", "8043512", "3010792309", "3021666757", "1720747", "3000268902", "3004765453", "3002821232", "1000391004", "3038614464", "3005771344", "3004598675", "1000181430", "3010394097", "3003882387", "3027556548", "3009685433", "3006252153", "3010774780", "3010000450", "3033536319", "3004095901", "3042989733", "3010675798", "3013557562", "3030626857", "1054713", "3011898560", "3006087789", "1000379039", "3027187888", "3005950902", "3003951061", "3030447506", "3035708926" ], "fei_number": [ "3013403214", "2918630", "1000114111", "3002807701", "3013188547", "1000582291", "3012494290", "3043126966", "1000140026", "3012421607", "3013298431", "3001124136", "3033882233", "2521877", "3010227033", "3005744933", "3027667933", "1316463", "3013436538", "3010792309", "3021666757", "1720747", "3000268902", "3004765453", "3002821232", "1000391004", "3038614464", "3005771344", "3004598675", "1000181430", "3010394097", "3003882387", "3027556548", "3009685433", "3006252153", "3010774780", "3010000450", "3033536319", "3004095901", "3042989733", "3010675798", "3013557562", "3030626857", "3011898560", "3003060634", "3006087789", "1000379039", "3027187888", "3005950902", "3003951061", "3030447506", "3035708926", "3003046678" ], "device_name": "Ophthalmoscope, Ac-Powered", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.1570", "device_class": "2" } } ] }