{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
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  "results": [
    {
      "cfres_id": "149494",
      "product_res_number": "Z-0093-2017",
      "event_date_initiated": "2016-09-13",
      "event_date_posted": "2016-10-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-02-09",
      "res_event_number": "75163",
      "product_code": "ORZ",
      "k_numbers": [
        "K112704",
        "K133127"
      ],
      "product_description": "LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100\n\nThe LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.",
      "code_info": "Lot 201615220020",
      "firm_fei_number": "3008169506",
      "recalling_firm": "Tearscience, Inc",
      "address_1": "5151 McCrimmon Pkwy Ste 250 5151 McCrimmon Pkwy",
      "address_2": "Ste 250",
      "city": "Morrisville",
      "state": "NC",
      "postal_code": "27560-5427",
      "additional_info_contact": "TearScience Customer Service\n919-459-4891",
      "reason_for_recall": "Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.",
      "root_cause_description": "Device Design",
      "action": "The firm, TearScience, sent a \"Medical Device Recall\" letter dated September 9, 2016 to its consignees/customers on 9/13/2016.  The letter described the product, problem and actions to be taken. The customers were instructed to complete and return the enclosed Acknowledgement and Receipt form by fax to (919) 882-9603, email  to: Customerservice@tearscience.com or mail to  TearScience, ATTN: CUSTOMER SERVICE RCL001, 5151 McCrimmon Parkway, Ste 250, Morrisville, NC 27560; to discontinue use of the product; to remove all a product with lot #201615220020 from your inventory; and call TearScience Customer Service at 919-459-4891 to return the product for above mentioned lot# and request new product for replacement.\n\nFor any questions regarding this letter, please call (919) 459-4891 Monday through Friday, 8:30AM to 5:30PM, Easter Time.",
      "product_quantity": "1,200 Activators (120 boxes of 10 units)",
      "distribution_pattern": "US Distribution including states of: AK, AR, CA, CO, FL, GA, ID, IL, IN, LA, MD, MA, MN, MO, NV, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA , WA, WI and Puerto Rico.",
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        "device_name": "Eyelid Thermal Pulsation System",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.5200",
        "device_class": "2"
      }
    }
  ]
}