{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "195356",
      "product_res_number": "Z-1672-2022",
      "event_date_initiated": "2022-07-08",
      "event_date_created": "2022-09-02",
      "recall_status": "Open, Classified",
      "res_event_number": "90661",
      "product_code": "MXK",
      "k_numbers": [
        "K201724"
      ],
      "product_description": "Pentacam AXL Wave REF 70020.  Used to image the anterior segment of the eye.",
      "code_info": "Software version: 1.26r26 and 1.26r27\n\nModel Number: 70020\nUDI-DI Code: 04049584025357\nSerial Numbers:\n70020 0111 0201\n70020 0211 0201\n70020 0311 0211\n70020 0711 1230\n70020 1211 0201\n70020 1321 1211\n70020 2411 0211\n70020 2911 1250\n70020 3511 0211\n70020 3801 0230\n70020 4701 0210\n70020 4811 1250\n70020 5411 0211\n70020 5701 0210\n70020 6611 1230\n70020 6621 1211\n70020 7011 0201\n70020 7511 1230\n70020 8021 1290\n70020 8701 0210\n70020 9011 0201",
      "firm_fei_number": "3002807782",
      "recalling_firm": "Oculus Optikgeraete GMBH",
      "address_1": "Munchholzhauser Str. 29 29 munchholzhauser str.",
      "city": "Wetzlar",
      "country": "Germany",
      "additional_info_contact": "425-6709977",
      "reason_for_recall": "Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs",
      "root_cause_description": "Software design",
      "action": "On 07/08/2022, OCULUS GmbH issued an \"Urgent safety information Corrective Action \" Letter to its subsidiary OCULUS Inc via UPS express which identifies a software error in the software version 1.26r26 and 1.26r27 in the IOL calculator of the Pentacam software.\n\nCorrective measures to be taken:\nA software update to version 1.26r28 must be performed on all computers used and affected in connection with the Pentacam and additional workstations.\nUsers should refrain from using the printout of the IOL calculator for affected installations until after the software update has been carried out.\n\nFor questions or support - contact OCULUS Inc Service Team at 425-670-9977 or email service@oculususa.com or fsca@oculus.de",
      "product_quantity": "21 systems with affected software",
      "distribution_pattern": "U.S.: AL, AR, AZ, CAQ, CO, CT, FL, GA, HI, IA, ID, IL, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, and WY\n\nO.U.S.: N/A",
      "openfda": {
        "k_number": [
          "K223700",
          "K051940",
          "K041841",
          "K052935",
          "K202989",
          "K222933",
          "K071183",
          "K984443",
          "K251848",
          "K040913",
          "K031788",
          "K182659",
          "K991284",
          "K030719",
          "K073508",
          "K201724",
          "K150754",
          "K191051",
          "K042742",
          "K152311",
          "K211868",
          "K030393",
          "K252348"
        ],
        "device_name": "Device, Analysis, Anterior Segment",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.1850",
        "device_class": "2",
        "registration_number": [
          "3009217531",
          "3035545084",
          "3003771740",
          "3009173773",
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        "fei_number": [
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          "4196",
          "3004441848",
          "3002807157",
          "3007913988"
        ]
      }
    }
  ]
}