{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "141530",
      "product_res_number": "Z-0357-2016",
      "event_date_initiated": "2015-10-27",
      "event_date_posted": "2015-12-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-06-06",
      "res_event_number": "72564",
      "product_code": "HJO",
      "k_numbers": [
        "K101182",
        "K122418",
        "K993357"
      ],
      "product_description": "IOL Master 5.5: Software versions 7.5 and 7.7;\n\nOphthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.",
      "code_info": "Software versions 7.5 and 7.7: Serial numbers:  1040306\t 1045450\t 1035312\t 1034011\t 1035310\t 1043145\t 1039588\t 1041805\t 1040321\t 1041803\t 1045443\t 1036716\t 1035318\t 1038800\t 1034016\t 1041838\t 1041833\t 1039587\t 1035291\t 1040313\t 1038795\t 1034051\t 1036553\t 1040314\t 1036539\t 1036702\t 1043952\t 1039614\t 1036541\t 1043121\t 1036786\t 1036713\t 1045455\t 1034801\t 1034792\t 1034071\t 1043117\t 1034795\t 1045451\t 1039611\t 1043941\t 1036693\t 1041836\t 1036532\t 1043132\t 1043134\t 1034073\t 1034822\t 1040315.",
      "firm_fei_number": "3001362763",
      "recalling_firm": "Carl Zeiss Meditec AG",
      "address_1": "Carl Zeiss Promenade 10 10 carl zeiss promenade",
      "city": "Jena",
      "country": "Germany",
      "additional_info_contact": "Judith A. Brimacombe, M.A.\n925-557-4616",
      "reason_for_recall": "IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.",
      "root_cause_description": "Software design",
      "action": "Urgent Medical Device Correction letters will be mailed on Friday, November 13, 2015 as the IOL SW update material is now available.  Letter informs customers of the issue and provide instructions for identifying the software version and for installing the software update with illustrations. \nAll customers are requested to complete and return the confirmation form to Stericycle as soon as the upgrade is complete or it has been determined that your unit is not running the affected version of the software.",
      "product_quantity": "49",
      "distribution_pattern": "Nationwide Distribution.",
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        "device_name": "Biomicroscope, Slit-Lamp, Ac-Powered",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.1850",
        "device_class": "2"
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}