{
  "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": "2026-09-09",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99496",
      "recalling_firm": "Johnson & Johnson Surgical Vision, Inc.",
      "address_1": "31 Technology Dr Ste 200",
      "address_2": "N/A",
      "postal_code": "92618-2302",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of PA, AL, AZ, AR, CA, FL, IL, IN, IA, KY, LA, ME, MI, MN, MS, NJ, NY, NC, OH, OR, TN, TX, WA, WV, HI, CO, MD, VA, WI, ID, NH, SD, OK, MA, NM, DE, GA, SC, CT, NV, MO, RI, KS, ND and the countries of CA, BE, CH, DE, DK, ES, FR GB, HU, IS, IT, NL, NO, PT, SE.",
      "recall_number": "Z-3064-2026",
      "product_description": "HEALON EndoCoat PRO, REF: 10300012 (US/CAN)   HEALON DUET PRO II, REF: 10300016 (US/CAN)    HEALON EndoCoat PRO, REF: 10301012 (EU);  HEALON DUET PRO II, REF: 10301016 (EU)",
      "product_quantity": "111,478",
      "reason_for_recall": "Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding because forcing the cannula may cause corneal abrasion, iris trauma or descemet's membrane detachment.",
      "recall_initiation_date": "20260731",
      "center_classification_date": "20260831",
      "report_date": "20260909",
      "code_info": "REF/UDI-DI/Lot: 10300012/5050474755093/UA32232, UA32250, UA32268, UA32290, UA32292, UA32303, UA32371, UP31203, UP31205;  10300016/5050474755116/UA32447, UA32448, UA32449, UB33008, UB33026, UB33082, UB33083, UB33175;  10301012/5050474755109/UB33014, UB33041, UB33057, UB33060, UB33100, UB33190;  10301016/5050474755123/UB33084, UB33194",
      "more_code_info": ""
    }
  ]
}