{
  "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": [
    {
      "country": "United States",
      "city": "Irvine",
      "address_1": "2525 Dupont Dr",
      "reason_for_recall": "Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the injector needle. The residual polishing compounds could transfer to the patient's eye during procedure possibly resulting in irritation, inflammation, local allergic reaction/ hypersensitivity, iritis, uveitis/sterile endophthalmitis or an intraocular foreign body.",
      "address_2": "",
      "product_quantity": "145,711  Glaucoma Treatment Systems",
      "code_info": "All Lots within Expiry:  US Lot codes: 61650, 61657, 61779, 61780, 61825, 61883, 61884, 61906, 61911, 62578, 62608, 62703, 62812, 62874 and 62941  OUS Lot codes: 61566, 61580, 61626, 61642, 61685, 61846, 61847, 61955, 61966, 62008, 62301, 62053, 62066, 62108, 62130, 62263, 62297, 62318, 62380, 62538, 62636, 62678, 62683, 62719, 62745, 62749, 62769 and 62890",
      "center_classification_date": "20191204",
      "distribution_pattern": "Worldwide distribution.  US nationwide, countries of AE, AT, AU, BE, BG, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, IE, IL, IS, IT, KR, LT, MT, MU, MX, MY, NA, NL, NO, NZ, PH, PL, PT, RO, RS, SA, SE, SG, SI,SK, SM,TH,TR, TW, VE, and ZA.",
      "state": "CA",
      "product_description": "XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model)  Implant for glaucoma treatment.",
      "report_date": "20191211",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Allergan PLC",
      "recall_number": "Z-0598-2020",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "84220",
      "more_code_info": "",
      "recall_initiation_date": "20191030",
      "postal_code": "92612-1531",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Ongoing"
    }
  ]
}