{
  "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": "113022",
      "product_res_number": "Z-0024-2013",
      "event_date_initiated": "2012-09-07",
      "event_date_posted": "2012-10-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-03-04",
      "res_event_number": "63211",
      "product_code": "OBO",
      "k_numbers": [
        "K091404",
        "K101505"
      ],
      "product_description": "Reference materials \"RETINAL OCT Analysis and Interpretation Method\" shipped with iVue System (K091404) and the \"Retina Poster\" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; \nThe physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA\n\nThe product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.",
      "code_info": "All units of these models.",
      "firm_fei_number": "3005950902",
      "recalling_firm": "Optovue Inc.",
      "address_1": "2800 Bayview Dr",
      "city": "Fremont",
      "state": "CA",
      "postal_code": "94538-6518",
      "additional_info_contact": "Azimun Jamal \n510-623-8868 Ext. 102",
      "reason_for_recall": "Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, \"The Retina\" poster provided with the systems, and the book \"RETINAL OCT Analysis and Interpretation Method\" by Bruno Lumbroso and Marco Rispoli which are not labeled within 51O(k) cleared product description.",
      "root_cause_description": "No Marketing Application",
      "action": "Optovue Inc., sent a Voluntary Field Correction and Removal letter dated September 6,  2012, to all affected customers. The letter identified the product the problem and the action to be taken by the customer .\n\nPlease sign and return the attached form indicating your acknowledgement that that the Affected Materials have been returned or destroyed. \n\nIf you have any further questions please contact Optovue, at 1-866-344-8948.",
      "product_quantity": "795 units",
      "distribution_pattern": "Worldwide Distribution -- USA (nationwide) and Internationally.",
      "openfda": {
        "k_number": [
          "K223557",
          "K233561",
          "K253837",
          "K231222",
          "K150977",
          "K112184",
          "K111157",
          "K162783",
          "K222200",
          "K111505",
          "K152205",
          "K063388",
          "K121622",
          "K181534",
          "K132323",
          "K240221",
          "K241081",
          "K083316",
          "K201252",
          "K180229",
          "K072971",
          "K133217",
          "K180660",
          "K141844",
          "K173707",
          "K233602",
          "K170164",
          "K250553",
          "K080460",
          "K101223",
          "K062552",
          "K163195",
          "K181594",
          "K172649",
          "K231673",
          "K241163",
          "K233933",
          "K252633",
          "K221601",
          "K121993",
          "K071839",
          "K192391",
          "K161194",
          "K182942",
          "K221320",
          "K071250",
          "K173648",
          "K182569",
          "K091404",
          "K233421",
          "K083291",
          "K200516",
          "K213265",
          "K063191",
          "K121043",
          "K163475",
          "K250868",
          "K173119",
          "K230897",
          "K222166",
          "K190732",
          "K113129",
          "K092470",
          "K211817",
          "K161509",
          "K240924"
        ],
        "registration_number": [
          "3013403214",
          "2918630",
          "9611269",
          "3004441848",
          "8020986",
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          "3003589956",
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          "3008348697",
          "3010000450",
          "3002807715",
          "9615030",
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          "1054713",
          "1000204638",
          "8030392",
          "3020723591",
          "3005950902",
          "3009746052"
        ],
        "fei_number": [
          "3013403214",
          "2918630",
          "1000114111",
          "1000582291",
          "4196",
          "3004441848",
          "2242863",
          "3002785343",
          "3005744933",
          "1000175127",
          "3003481798",
          "3008729548",
          "3038356864",
          "3038614464",
          "1000181430",
          "2936921",
          "3002680900",
          "3003589956",
          "3001362763",
          "3008348697",
          "3010000450",
          "3002807782",
          "3002807715",
          "3002807157",
          "3003768492",
          "1000204638",
          "3020723591",
          "3003060634",
          "3005950902",
          "3009746052"
        ],
        "device_name": "Tomography, Optical Coherence",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.1570",
        "device_class": "2"
      }
    }
  ]
}