{
  "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": "203536",
      "product_res_number": "Z-0183-2024",
      "event_date_initiated": "2023-08-18",
      "event_date_posted": "2023-10-26",
      "recall_status": "Open, Classified",
      "res_event_number": "93146",
      "product_code": "FSO",
      "product_description": "OPMI LUMERA 300, REF 6137",
      "code_info": "UDI-DI/Serial Numbers: 06909262061375/6137104455, 6137104627, 6137104623,\n6137104678, 6137104233, 6137104620, 6137104480, 6137104613",
      "firm_fei_number": "3008564898",
      "recalling_firm": "Carl Zeiss Suzhou Co., Ltd.",
      "address_1": "Modern Industrial Square 3b No. 333 Xingpu Road",
      "city": "Suzhou",
      "state": "Kunshan",
      "country": "China",
      "reason_for_recall": "Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspension arm, which may injure any person under the suspended components.",
      "root_cause_description": "Process control",
      "action": "On 8/18/23, correction notices were mailed to customers who were asked to do the following:\n\nBefore each use of the affected device, perform the following mandatory inspection:\n\nRefer to pictures in the notice showing a gap between the OPMI and the inspection arm. This gap should not be greater than 5mm. \n\nIf the gap is greater than 5mm, please Immediately stop using the device! In this case the affected device can no longer be used. \n\nThe firm is planning to inspect (repair if needed) the suspension arm immediately. Service staff will contact you to arrange an appointment for inspection (repair if needed) of the suspension arm.\n\nComplete and return the acknowledgement and receipt form and return to USFCA.meditec.us@zeiss.com\n\nIf you have any questions, contact firm Customer Support at 877-486-7473.",
      "product_quantity": "8",
      "distribution_pattern": "US Nationwide distribution in the states of MD, TX, CA, GA, LA.",
      "openfda": {
        "k_number": [
          "K802713",
          "K874241",
          "K926513",
          "K920689",
          "K902076",
          "K941399",
          "K822181",
          "K791280",
          "K822015",
          "K801314",
          "K931303",
          "K822562",
          "K942304",
          "K926288",
          "K910357"
        ],
        "registration_number": [
          "",
          "8030607",
          "3009340886",
          "1528142",
          "3007123908",
          "1000204638",
          "3001644167",
          "3006252153",
          "3009598746",
          "3013154160",
          "3014059828",
          "3013351723",
          "3015180671",
          "3003851947",
          "3005527904",
          "2916714",
          "3014644251",
          "3044710739",
          "9610612",
          "3002821232",
          "2020550",
          "3042172882",
          "3013403214",
          "3031700059",
          "3005273623",
          "3010242141",
          "3010202439",
          "3005755367",
          "3003974370",
          "1054713",
          "3003591740",
          "3006543022",
          "8010573",
          "3008590661",
          "3029755582",
          "3005527296",
          "2127132",
          "1836161",
          "3030390145",
          "3014388471",
          "3014683120",
          "3025436467",
          "9615010",
          "3032734659",
          "1820334",
          "1645452",
          "3009560832"
        ],
        "fei_number": [
          "",
          "3009340886",
          "3002750084",
          "1000122772",
          "1000204638",
          "3007123908",
          "3001644167",
          "3006252153",
          "3009598746",
          "3013154160",
          "3014059828",
          "3013351723",
          "3007475226",
          "3015180671",
          "3003851947",
          "3005527904",
          "2916714",
          "3014644251",
          "3044710739",
          "3002821232",
          "2020550",
          "3042172882",
          "3013403214",
          "3031700059",
          "3003481798",
          "3005273623",
          "3010242141",
          "3003974370",
          "3005755367",
          "3003591740",
          "3006543022",
          "3002806315",
          "3008590661",
          "3029755582",
          "3005527296",
          "2127132",
          "3030390145",
          "1000139591",
          "3014388471",
          "3014683120",
          "3006509795",
          "3025436467",
          "3032734659",
          "1820334",
          "1000114111",
          "3003169291",
          "3009560832"
        ],
        "device_name": "Microscope, Surgical, General & Plastic Surgery",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4700",
        "device_class": "1"
      }
    }
  ]
}