{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "167050",
      "product_res_number": "Z-0187-2019",
      "event_date_initiated": "2018-08-28",
      "event_date_posted": "2018-10-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-12-18",
      "res_event_number": "80931",
      "product_code": "OGO",
      "pma_numbers": [
        "P150037"
      ],
      "product_description": "CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #:  8065754007.    For ophthalmic use.",
      "code_info": "GTIN: 00380657540075, 10380657540072, 20380657540079  All lot/serial numbers",
      "firm_fei_number": "2523835",
      "recalling_firm": "Alcon Research, LTD.",
      "address_1": "714 Columbia Ave",
      "city": "Sinking Spring",
      "state": "PA",
      "postal_code": "19608-1405",
      "additional_info_contact": "Customer Services\n800-862-5266",
      "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.",
      "root_cause_description": "Device Design",
      "action": "The firm initiated their market withdrawal by letter on 08/28/2018.  The firm requested surgeons immediately cease implantation of the device and return any unused product.",
      "product_quantity": "38682 units",
      "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.",
      "openfda": {
        "pma_number": [
          "P150037",
          "P080030",
          "P170034",
          "P000026",
          "P170043"
        ],
        "registration_number": [
          "3011065920",
          "3015217553",
          "1319660",
          "2523835",
          "2029275",
          "3010208880",
          "2022435",
          "3012833022",
          "3023475296"
        ],
        "fei_number": [
          "3011065920",
          "3015217553",
          "2523835",
          "1000306431",
          "3010208880",
          "2022435",
          "3012341472",
          "3023475296",
          "1000136478"
        ],
        "device_name": "Intraocular Pressure Lowering Implant",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}