{ "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": "157859", "product_res_number": "Z-0009-2018", "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": "HKI", "k_numbers": [ "K130656" ], "product_description": "iFusion, Device Listing Number D203271.\n\nProduct 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\ndocumentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND \n\niVue 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\nand 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\nretina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects.", "code_info": "Cat No. 700-49001-001 (GTIN - N/A), 700-49001-003 (GTIN - N/A), 700-49001-004 (GTIN 00858848006186).", "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": [ "K003236", "K120982", "K770888", "K973950", "K201325", "K123101", "K182263", "K031629", "K014274", "K852638", "K980246", "K190954", "K873157", "K010315", "K102412", "K203500", "K023719", "K092056", "K201122", "K122572", "K070231", "K822908", "K083771", "K953972", "K020888", "K092565", "K082196", "K090115", "K974535", "K102013", "K243600", "K183059", "K153239", "K081858", "K090326", "K823719", "K141481", "K173474", "K843021", "K250683", "K083387", "K022164", "K123460", "K930442", "K190198", "K980357", "K061768", "K946058", "K252120", "K080883", "K973218", "K130656", "K884989", "K844898", "K874355", "K223381", "K002920", "K952480", "K001275", "K113451", "K041367", "K091098", "K251353", "K822991", "K063717", "K132987", "K123208", "K062021", "K982689", "K862323", "K180378", "K062295", "K230627", "K050271", "K043222", "K200254", "K062356", "K855170", "K011877", "K954780", "K913929", "K102859", "K934663", "K092374", "K913314", "K911439", "K101935", "K202221", "K140450", "K923958", "K000368", "K041546", "K210197", "K052268", "K101861", "K221111", "K053026", "K152729", "K163021", "K190573", "K093071", "K182506", "K242508", "K973533", "K980295", "K990205", "K062416", "K923708", "K874017", "K954781", "K221329", "K223575", "K080681", "K122481", "K972440", "K231230", "K112330", "K843899", "K193319", "K043213", "K091935", "K941234", "K963333", "K182199", "K253176", "K040325", "K950091", "K090466", "K161727", "K170527", "K955442", "K100207", "K101628", "K141325", "K243664", "K091683", "K110986", "K180306", "K111771", "K191945", "K132186", "K121405", "K080180", "K082767", "K895474", "K953973", "K250770", "K971685", "K152869", "K102651", "K854330", "K833694", "K241049", "K053044", "K130289", "K111612", "K202097" ], "registration_number": [ "3013403214", "2918630", "2320749", "3006546174", "3009990264", "3004441848", "3012096560", "8020986", "8010482", "9612197", "2242863", "3003771740", "2521877", "1222616", "3012162565", "9614661", "3015972897", "2080939", "3003144120", "3005755367", "1316463", "3004026651", "3008729548", "3038356864", "3014606890", "3011223751", "3010363436", "3017175640", "3007913988", "3007237389", "3010792309", "3005785090", "3003500271", "3004443844", "1000391004", "1926681", "3038614464", "1000181430", "3010394097", "3014342096", "2027009", "3007710608", "2936921", "3008252121", "3010069263", "9616199", "3008396732", "3010202439", "3016589969", "3009173773", "3010000450", "3038790635", "3002807715", "9615030", "1319721", "1054713", "9617474", "3004848970", "8030392", "3015316279", "3006087789", "1528142", "3005950902", "2020550", "3009746052", "3008169506" ], "fei_number": [ "3013403214", "2918630", "3006546174", "1000114111", "1000582291", "4196", "3004099094", "3009990264", "3004441848", "3012096560", "1000159913", "3002807554", "2242863", "3003004358", "1000292048", "3003771740", "2521877", "3012162565", "3007475226", "3015972897", "2080939", "1000175127", "3005755367", "1316463", "3010363436", "3008729548", "3038356864", "3014606890", "3011223751", "3017175640", "3007913988", "3007237389", "3010792309", "3005785090", "3003500271", "3004443844", "3002398337", "1000391004", "1926681", "3038614464", "1000181430", "3010394097", "3014342096", "1000122772", "2027009", "3007710608", "2936921", "3008252121", "3010069263", "3008396732", "1000120916", "3016589969", "3009173773", "3001362763", "3010000450", "3038790635", "3002807715", "3003768492", "3004848970", "3015316279", "3006087789", "2020550", "3005950902", "3009746052", "3008169506" ], "device_name": "Camera, Ophthalmic, Ac-Powered", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.1120", "device_class": "2" } } ] }