{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Sinking Spring",
      "state": "PA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80931",
      "recalling_firm": "Alcon Research, LTD.",
      "address_1": "714 Columbia Ave",
      "address_2": "N/A",
      "postal_code": "19608-1405",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution.  US nationwide including Puerto Rico, Argentina, Australia, Austria, Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, France, Finland, Germany, Hong Kong, Iceland, Italy, Mexico, Peru, Singapore, Spain, Sweden, Switzerland, United Kingdom, and Uruguay.",
      "recall_number": "Z-0186-2019",
      "product_description": "CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF:  8065754001.   For ophthalmic use.",
      "product_quantity": "14264 units",
      "reason_for_recall": "Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone.",
      "recall_initiation_date": "20180828",
      "center_classification_date": "20181023",
      "termination_date": "20201218",
      "report_date": "20181031",
      "code_info": "GTIN: 00380657540013, 0080657540013, 20380657540017, 10380657540010, 00380657540013  All lot/serial numbers"
    }
  ]
}