{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "172948",
      "product_res_number": "Z-1893-2019",
      "event_date_initiated": "2018-09-24",
      "event_date_created": "2019-06-28",
      "recall_status": "Terminated",
      "res_event_number": "82868",
      "product_code": "MLZ",
      "k_numbers": [
        "K081681"
      ],
      "product_description": "Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc.,  \n\nThe product provides the item necessary to perform one vitrectomy procedure. It is used to remove vitreous from the eye. It has been designed as a disposable (single use)",
      "code_info": "Lot Number: 60084881 Mfg. date: 2017-09-05 Exp. date: 2020-09-05 UDI: (01)05050474534117 (17)200905(10)60084881",
      "firm_fei_number": "3003843509",
      "recalling_firm": "Johnson & Johnson Surgical Vision Inc",
      "address_1": "1700 E Saint Andrew Pl",
      "city": "Santa Ana",
      "state": "CA",
      "postal_code": "92705-4933",
      "additional_info_contact": "Sherly Jules-Fleury\n877-266-4543",
      "reason_for_recall": "Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package.  Use of a Vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including corneal incision enlargement.",
      "root_cause_description": "Packaging process control",
      "action": "The firm, Johnson & Johnson Vision, sent an\"URGENT MEDICAL DEVICE RECALL\" Letter dated September 20, 2018 overnight on September 20, 2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:  \n\nIf you have received impacted product, please immediately take the following actions:\n1. Review your inventory to identify units of affected lot; 2. Stop using and remove from your inventory all affected lot; and 3. regardless if you do not have inventory, please complete the Customer Reply form and return product.  \n\nIf you have questions, please contact the firm at 1-877-166-4543.",
      "product_quantity": "392 units",
      "distribution_pattern": "US Distribution to states of: NC, NV, TX, NY, UT, C, MN, NY, WA, NJ, OH, NV, CA and Internationally to: Australia and Japan.",
      "openfda": {
        "k_number": [
          "K170520",
          "K093305",
          "K081681",
          "K220030"
        ],
        "registration_number": [
          "3010291427",
          "2953359",
          "2028159",
          "3015456951",
          "3029973819",
          "1644019",
          "3005012805",
          "3033485955",
          "1650907",
          "9681572",
          "3010208880",
          "3012236936",
          "3012123033",
          "3003398873",
          "3010047402",
          "2126666",
          "1649518",
          "3008692839",
          "2523835",
          "3023125126",
          "2935428",
          "1928237",
          "3005941719",
          "1319660"
        ],
        "fei_number": [
          "3010291427",
          "3015456951",
          "1000136478",
          "3029973819",
          "3005012805",
          "1000221463",
          "3033485955",
          "3010208880",
          "3012236936",
          "1000125771",
          "3012123033",
          "3003398873",
          "3010047402",
          "2126666",
          "3003263857",
          "3002681132",
          "3008692839",
          "2523835",
          "3023125126",
          "3000215205",
          "3001236277",
          "1928237",
          "3002807111",
          "1000117501"
        ],
        "device_name": "Vitrectomy, Instrument Cutter",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.4150",
        "device_class": "2"
      }
    }
  ]
}