{
  "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",
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      "cfres_id": "190548",
      "product_res_number": "Z-0410-2022",
      "event_date_initiated": "2021-11-17",
      "event_date_created": "2021-12-21",
      "recall_status": "Open, Classified",
      "res_event_number": "89111",
      "product_code": "PZG",
      "product_description": "Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery.\nPart Number: MMK967",
      "code_info": "Lot Numbers: 3347922, 3350452, 3354937, 3358047, 3364371",
      "firm_fei_number": "1211998",
      "recalling_firm": "Beaver Visitec International, Inc.",
      "address_1": "500 Totten Pond Rd 10 City Point",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02451-1916",
      "additional_info_contact": "SAME\n781-906-7950",
      "reason_for_recall": "Kit packaging may have small holes compromising product sterility",
      "root_cause_description": "Packaging change control",
      "action": "Beaver Visitec issued Urgent Medical Device Recall notification dated  11/17/21 to the first level consignee. Letter states reason for recall, health risk and action to take:\nPLEASE perform the following actions:\n1. Immediately examine your inventory and quarantine product from these lots that are subject to recall.\nIf you have further distributed this product, please notify your customers by initiating a sub-recall. Consider all potential users of this product in your user supply chain. You are encouraged\nto use a copy of this recall notification letter when contacting your customers.\n2. Complete the enclosed Business Reply Form (BRF) and indicate whether you have affected product to return.\n3. Please enter the following information on the enclosed BRF: part number(s), lot number(s) and quantity(ies) of device(s) that are being returned.\n\n4. Return the completed BRF to BVI by one of these methods:\n\" Fax to 866-912-8416\n\" Email the attached to beavervisitec3570@sedgwick.com\n5. Return your product to STERICYCLE using the enclosed UPS pre-paid return label:\nStericycle\n2670 Executive Drive, Suite A\nIndianapolis, IN 46241\nAttn: Event 3570\nIf you have questions regarding the return procedure, please contact Stericycle Inc. at 866-625-5325 (Mon.-Fri. 8:00 am - 5:00 pm Eastern Time).",
      "product_quantity": "1170 units",
      "distribution_pattern": "CA, CO, LA, MA, MD, ND, PA, TN, UT",
      "openfda": {
        "device_name": "Surgical Eye Tray",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.4350",
        "device_class": "1",
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