{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "25239",
      "product_res_number": "Z-0530-03",
      "event_date_initiated": "2002-11-29",
      "event_date_posted": "2003-02-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-02-06",
      "res_event_number": "25123",
      "product_code": "HQX",
      "k_numbers": [
        "K972661"
      ],
      "product_description": "Venus Eye Sphere 16 mm (Sterile)",
      "code_info": "model number 14153. lot number 8159",
      "firm_fei_number": "2518410",
      "recalling_firm": "Gulden Ophthalmics",
      "address_1": "225 Cadwalader Ave",
      "city": "Elkins Park",
      "state": "PA",
      "postal_code": "19027-2020",
      "additional_info_contact": "Thomas D. Cockley\n215-884-8105",
      "reason_for_recall": "lack of sterility assurance",
      "root_cause_description": "Other",
      "action": "The recalling firm issued letters to the accounts requesting the return of the devices.",
      "distribution_pattern": "Nationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand",
      "openfda": {
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          "K863946",
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          "K832481",
          "K963219",
          "K900930",
          "K902308",
          "K800140",
          "K950806",
          "K023481"
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        "registration_number": [
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          "3005941719",
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          "3010162973",
          "1218813",
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          "9611516",
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        "fei_number": [
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          "3002445546",
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          "1220477",
          "3002532015"
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        "device_name": "Implant, Orbital, Extra-Ocular",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.3340",
        "device_class": "2"
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}