{
  "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": {
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  "results": [
    {
      "cfres_id": "70296",
      "product_res_number": "Z-0103-2009",
      "event_date_initiated": "2008-04-23",
      "event_date_posted": "2008-10-22",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-04-02",
      "res_event_number": "47839",
      "product_code": "HNO",
      "k_numbers": [
        "K040204"
      ],
      "product_description": "Zyoptix XP Microkeratome maxon motor, Ref #ZXP09183.  The label shows the product is manufactured by Bausch & Lomb Incorporated, Rochester, NY.",
      "code_info": "Serial numbers:  77318901, 77318902, 77318903, 77318904, 77318905, 77318907, 77318910, 77318911, 77318913, 77318914, 77318915, 77318917, 77318918, 77318919, 77318922, 77318923, 77318924, 77318929, 77318930, 77318931, 77318932, 77504010, 77504012, 77504017, 77732304, 77732306, 77732308, 77732309, 77732310, 77732311, 77732312, 77732313, 77732314, 77732315, 77898709, 77898711, 78080303, 78080307, 78080308, 78080309, 78080310, 78080312, 78080313, 78080314, 78080315, 78080320, 78080322, 78080331, 78080337, 78207103, 78207104, 78207106, 78207107, 78207108, 78207111, 78207113, 78207114, 78207115, 78207116, 78207117, 78207118, 78207119, 78207120, 78207121, 78207122, 78207123, 78207124, 78207125, 78207129.",
      "firm_fei_number": "1317628",
      "recalling_firm": "Bausch & Lomb Inc",
      "address_1": "1400 North Goodman Street",
      "city": "Rochester",
      "state": "NY",
      "postal_code": "14609-3547",
      "additional_info_contact": "Mike Judy\n585-338-6000",
      "reason_for_recall": "The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating.",
      "root_cause_description": "Device Design",
      "action": "Phone calls were initiated on 4/28/08 and an Urgent Recall letter dated 4/23/08 was issued 4/28/08 via overnight mail to U.S. customers explaining the reason for recall.  The letter also requested that customers stop using the motors identified and return of the motors for evaluation.  A return form was enclosed.",
      "product_quantity": "69 motors",
      "distribution_pattern": "Worldwide Distribution --- including USA and countries of Brazil, The Netherlands, Canada, India, Malaysia, Mexico, and Singapore.",
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        "device_name": "Keratome, Ac-Powered",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.4370",
        "device_class": "1"
      }
    }
  ]
}