{
  "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": "122717",
      "product_res_number": "Z-0275-2014",
      "event_date_initiated": "2013-08-12",
      "event_date_posted": "2013-11-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-08-04",
      "res_event_number": "66608",
      "product_code": "HOZ",
      "product_description": "DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer:  DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN  37849, MADE IN GUATEMALA\r\n\r\ncleaning of fluids from surgical site in or near the eye",
      "code_info": "Lot Number 32794811",
      "firm_fei_number": "1043214",
      "recalling_firm": "DeRoyal Industries Inc",
      "address_1": "200 Debusk Ln",
      "city": "Powell",
      "state": "TN",
      "postal_code": "37849-4703",
      "additional_info_contact": "Mr. Tracy Edmundson\n865-362-2334",
      "reason_for_recall": "One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.",
      "root_cause_description": "Employee error",
      "action": "DeRoyal Industries sent an Urgent Voluntary Recall letter dated August 12, 2013, to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed to  cease usage and return the product to:\r\nDeRoyal Recalls\r\nRA#:  Eye Spears\r\n1755 Hwy 33 South\r\nNew Tazewell, TN  37825\r\nShip via UPS Ground using Shipper #312780\r\n Distributors were requested to notify their consignees of the same.  The recall is extended to the user level.  Customers with questions were instructed to call 1-800-251-9864.\r\nFor questions regarding this recall call 865-362-2334.",
      "product_quantity": "726 cases (7242 units)",
      "distribution_pattern": "Nationwide Distribution",
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        "device_name": "Sponge, Ophthalmic",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.4790",
        "device_class": "2"
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    }
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}