{
  "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,
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  },
  "results": [
    {
      "cfres_id": "25236",
      "product_res_number": "Z-0540-03",
      "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 10 mm (Sterile)",
      "code_info": "model number 14150. lot number 7381",
      "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.",
      "product_quantity": "1096 total units",
      "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": {
        "k_number": [
          "K983581",
          "K023481",
          "K950806",
          "K901002",
          "K950599",
          "K832481",
          "K900929",
          "K963219",
          "K900930",
          "K863946",
          "K945172",
          "K980816",
          "K902308",
          "K900927",
          "K900928",
          "K800140"
        ],
        "registration_number": [
          "1218813",
          "2031962",
          "3009337401",
          "3010162973",
          "3002991496",
          "3004467263",
          "9611516",
          "1000286794",
          "9615745",
          "3002807090",
          "1226011",
          "3005941719",
          "1220477"
        ],
        "fei_number": [
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          "3000314405",
          "3002445546",
          "3009337401",
          "3002991496",
          "3004467263",
          "1000286794",
          "3006003617",
          "3002807111",
          "3002532015",
          "3002806863",
          "1218813",
          "1220477"
        ],
        "device_name": "Implant, Orbital, Extra-Ocular",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.3340",
        "device_class": "2"
      }
    }
  ]
}