{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "192949",
      "product_res_number": "Z-1001-2022",
      "event_date_initiated": "2022-03-23",
      "event_date_created": "2022-04-25",
      "recall_status": "Open, Classified",
      "res_event_number": "89939",
      "product_code": "ORZ",
      "product_description": "TearCare version 1.0 SmartHubs",
      "code_info": "UDI/DI: 00858027006273;\nLots: 1007076 through 1007406, 133914 through 137646, and 846004203 through 846237811.",
      "firm_fei_number": "3010363671",
      "recalling_firm": "Sight Sciences, Inc.",
      "address_1": "4040 Campbell Ave",
      "address_2": "Suite 100",
      "city": "Menlo Park",
      "state": "CA",
      "postal_code": "94025-1052",
      "reason_for_recall": "Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) exemption and so their performance characteristics were not evaluated by the FDA prior to distribution.",
      "root_cause_description": "No Marketing Application",
      "action": "On 03/23/22, recall notices were mailed to customers who were informed that the recalling firm intends to send new 510(k)-cleared devices, version 1.5, to replace affected devices. Customers were asked to do the following:\n\n1) After receiving the new devices, return the affected devices to the recalling firm.\n2) Complete and return the response form.\n\nCustomers questions can contact customer service at: 877-266-1144 or TearCareContactUs@sightsciences.com",
      "product_quantity": "921",
      "distribution_pattern": "US Nationwide distribution in the states of PA, CA, OH, AZ, CT, NC, GA, TN, MS, RI, WA, IL, FL, NV, NE, VA, SD, KY, OK, NJ, CO, TX, MI, NY, AR, WI, OR, MO, AL, NM, UT, WV, SC, IN, KS, MA, MN, NH, MT, ND, MD, WY, HI, DC, ID, LA, DE.",
      "openfda": {
        "k_number": [
          "K262479",
          "DEN100017",
          "K161357",
          "K192623",
          "K231084",
          "K172645",
          "K242786",
          "K133127",
          "K240512",
          "K112704",
          "K213045",
          "K252409",
          "K200400"
        ],
        "registration_number": [
          "3010162782",
          "2028159",
          "3006262888",
          "1610287",
          "3012500984",
          "3010363671",
          "3009265194",
          "3014193078",
          "2183744",
          "2031044",
          "1036836",
          "3010208880",
          "3008169506",
          "3003144120",
          "3017056829",
          "8043396",
          "3007113251"
        ],
        "fei_number": [
          "3010162782",
          "3004099094",
          "3006262888",
          "1610287",
          "3012500984",
          "3005461046",
          "3010363671",
          "3009265194",
          "3014193078",
          "1000125771",
          "2183744",
          "3001236763",
          "1036836",
          "3010208880",
          "3008169506",
          "3017056829",
          "3007113251"
        ],
        "device_name": "Eyelid Thermal Pulsation System",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.5200",
        "device_class": "2"
      }
    }
  ]
}