{
  "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": "2026-09-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "221673",
      "product_res_number": "Z-3064-2026",
      "event_date_initiated": "2026-07-31",
      "event_date_posted": "2026-08-31",
      "recall_status": "Open, Classified",
      "res_event_number": "99496",
      "product_code": "LZP",
      "pma_numbers": [
        "P810031S078"
      ],
      "product_description": "HEALON EndoCoat PRO, REF: 10300012 (US/CAN) \r\nHEALON DUET PRO II, REF: 10300016 (US/CAN)  \r\nHEALON EndoCoat PRO, REF: 10301012 (EU);\r\nHEALON DUET PRO II, REF: 10301016 (EU)",
      "code_info": "REF/UDI-DI/Lot:\n10300012/5050474755093/UA32232, UA32250, UA32268, UA32290, UA32292, UA32303, UA32371, UP31203, UP31205;\n\n10300016/5050474755116/UA32447, UA32448, UA32449, UB33008, UB33026, UB33082, UB33083, UB33175;\n\n10301012/5050474755109/UB33014, UB33041, UB33057, UB33060, UB33100, UB33190;\n\n10301016/5050474755123/UB33084, UB33194",
      "firm_fei_number": "3012236936",
      "recalling_firm": "Johnson & Johnson Surgical Vision, Inc.",
      "address_1": "31 Technology Dr Ste 200 31 Technology Dr",
      "address_2": "Ste 200",
      "city": "Irvine",
      "state": "CA",
      "postal_code": "92618-2302",
      "additional_info_contact": "Global Post Market Safety\n877-266-4543",
      "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.",
      "root_cause_description": "Device Design",
      "action": "On 7/31/2026, correction notices were mailed to customers and distributors informing them of the following:\nDevice Insertion Technique Clarification:\nIf resistance is encountered during insertion, withdraw the cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding. Do not force the cannula through the incision, as this may increase the risk of unintended tissue injury, including, but not limited to corneal abrasion, iris trauma or Descemet s Membrane Detachment, which may require medical or surgical intervention to preclude serious injury.\n\nThis investigation is currently ongoing, and we will notify users if any additional information comes to light.\n\n1) Forward this notice to all surgeons using this device in your facility.\n2) If any of the subject product has been transported to another facility/surgeon, contact that facility/surgeon and provide/forward this notice to them.\n3) Keep a copy of this notice with the subject product.\n4) Complete, sign, and return the Business Reply Form via email to RegCompliOne@its.jnj.com\n\nIf you have questions or concerns with regard to this notification, please contact the firm's Global Post Market Safety Team at 1-877-266-4543, Option 2.\n\nAdditional notices with additional affected devices to be sent in the future.",
      "product_quantity": "111,478",
      "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.",
      "openfda": {
        "pma_number": [
          "P890047",
          "P810031",
          "P820079",
          "P880031",
          "P840064",
          "P000046",
          "P200025",
          "P860047",
          "P110007",
          "P900010",
          "P990023",
          "P810025",
          "P220009",
          "P960011"
        ],
        "registration_number": [
          "3002037047",
          "1313525",
          "2529709",
          "3011965331",
          "2184002",
          "3015456951",
          "3007093114",
          "2183744",
          "3012236936",
          "1610287",
          "3000164186",
          "1064514",
          "2083373",
          "9710098",
          "1119279",
          "1037089",
          "3004750704",
          "3009337401",
          "1211998",
          "1038833",
          "3005941719",
          "3003477135",
          "3039186269",
          "1424263"
        ],
        "fei_number": [
          "3002037047",
          "1317628",
          "3011965331",
          "3015456951",
          "3007093114",
          "2183744",
          "3012236936",
          "1610287",
          "3003015552",
          "1000121259",
          "3000164186",
          "3002807111",
          "2083373",
          "3002957101",
          "1119279",
          "1037089",
          "3004161528",
          "3004750704",
          "3009337401",
          "1211998",
          "1038833",
          "3003477135",
          "3039186269",
          "1000115753"
        ],
        "device_name": "Aid, Surgical, Viscoelastic",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.4275",
        "device_class": "3"
      }
    }
  ]
}