{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "121305",
      "product_res_number": "Z-0144-2014",
      "event_date_initiated": "2013-06-27",
      "event_date_posted": "2013-11-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-09-27",
      "res_event_number": "66040",
      "product_code": "HNJ",
      "product_description": "MLS Torpedo Mini-Light Ophthalmic single-port illumination.\n\nSutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.",
      "code_info": "Part Number    Lot Number     Expiration 11007                M52934            04/2013 11017                M53017            04/2013 11007                M55285            07/2013 11007                M55869            08/2013 11007                M58610            12/2013 11007                M59575            02/2014 11007                M61781            05/2014",
      "firm_fei_number": "1052234",
      "recalling_firm": "Insight Instruments, Inc.",
      "address_1": "2580 Se Willoughby Blvd",
      "city": "Stuart",
      "state": "FL",
      "postal_code": "34994-4701",
      "additional_info_contact": "Ross McDonough\n727-219-9393",
      "reason_for_recall": "The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance.",
      "root_cause_description": "No Marketing Application",
      "action": "Insight Instruments, Inc. sent a letter dated April 8, 2013, via USPS priority mail to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed to discontinue using and dispensing all affected product, perform a physical count of their inventory and complete the Return Response Form and fax to 772-219-9342.   Customers were also instructed to call 800-255-8354 to arrange for return and prompt reimbursement.\nFor questions regarding this recall call 727-219-9393.",
      "product_quantity": "10212",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) including AZ, CA, FL, IN, MA, MD, TX, and WA and Internationally to Czech Republic, Germany, Netherlands, Spain, Switzerland, and Turkey.",
      "openfda": {
        "k_number": [
          "K830335",
          "K871646",
          "K791988"
        ],
        "registration_number": [
          "3004001706",
          "1421879",
          "2244478",
          "3005225959",
          "3008342610",
          "3031231776",
          "9611502",
          "3030451558",
          "3015177648",
          "1932180",
          "1058726",
          "9615857",
          "3005528784",
          "3008719017",
          "3003244954",
          "3013503739",
          "3040185492",
          "3042940336",
          "1045379",
          "8040278",
          "2521877",
          "8010374",
          "3011110913",
          "9680518",
          "9611283",
          "3017857440",
          "3008808049",
          "3000264417",
          "2242450",
          "1056350",
          "3003039352",
          "1836161",
          "2031962",
          "3042228518",
          "1211998",
          "3010383847",
          "3012267976",
          "3019924",
          "9680620",
          "3029754081",
          "1646747",
          "3013398127",
          "9617768",
          "3010041511",
          "8040381",
          "3012733432",
          "1926681",
          "1720747",
          "9613079",
          "1421101",
          "1923569",
          "9616250",
          "3013576617",
          "2529846",
          "3004215117",
          "3012185136",
          "3009027787",
          "3010155661",
          "3001967056",
          "9680718",
          "9616245",
          "3006550126",
          "8043368",
          "3005067367",
          "3011137372",
          "3009513193",
          "1061927",
          "8043816",
          "8040382",
          "3006380247",
          "3007589150",
          "3004571672",
          "3035708926",
          "9615659",
          "3007648354",
          "1319639",
          "3008770252",
          "1313525"
        ],
        "fei_number": [
          "3004001706",
          "3005734757",
          "3005225959",
          "3008342610",
          "3005304066",
          "3031231776",
          "3030451558",
          "3015177648",
          "1000307733",
          "3005528784",
          "3008719017",
          "3003244954",
          "3005747797",
          "3013503739",
          "3040185492",
          "3042940336",
          "1045379",
          "3002409980",
          "1000119305",
          "1000138054",
          "3000280067",
          "1000136191",
          "2521877",
          "3011110913",
          "6749",
          "3017857440",
          "3008808049",
          "3000203000",
          "3000264417",
          "2242450",
          "3003039352",
          "1000140363",
          "3042228518",
          "3002750084",
          "1211998",
          "3010383847",
          "3012267976",
          "3019924",
          "1000194896",
          "3029754081",
          "1317628",
          "1000160162",
          "3013398127",
          "3010041511",
          "1000246164",
          "3012733432",
          "1926681",
          "3546",
          "1720747",
          "1421101",
          "3003289411",
          "3002808441",
          "1923569",
          "3013576617",
          "3004215117",
          "3012185136",
          "3009027787",
          "3010155661",
          "3001967056",
          "3006550126",
          "3002807214",
          "3004216008",
          "3003408840",
          "3002806816",
          "1000115048",
          "3003772581",
          "3009513193",
          "3006380247",
          "3007589150",
          "3002445546",
          "3002806755",
          "3004571672",
          "3035708926",
          "3007648354",
          "3008770252",
          "1000136269",
          "3005693456",
          "6750"
        ],
        "device_name": "Punch, Corneo-Scleral",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.4350",
        "device_class": "1"
      }
    }
  ]
}