{
  "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-0187-2019",
      "product_description": "CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #:  8065754007.    For ophthalmic use.",
      "product_quantity": "38682 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: 00380657540075, 10380657540072, 20380657540079   All lot/serial numbers"
    }
  ]
}