{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "83806",
      "product_res_number": "Z-0904-2011",
      "event_date_initiated": "2009-05-18",
      "event_date_posted": "2011-01-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-02-09",
      "res_event_number": "52716",
      "product_code": "EPT",
      "product_description": "VISU 200 on S8 Floor Stand, Manufactured by Carl Zeiss Surgical GmbH, Germany\nMedical device: Surgical microscope used during ophthalmic surgeries, which allows real time visualization of the surgical area. \nProduct Quantity Distributed (Int) 2540 units",
      "code_info": "User manuals with numbers G-30-1246-e, G-30-1284-e, G-30-1284-en, and G-30-1236-en, affecting all stands.",
      "firm_fei_number": "2918630",
      "recalling_firm": "Carl Zeiss Meditec Inc",
      "address_1": "5160 Hacienda Dr",
      "city": "Dublin",
      "state": "CA",
      "postal_code": "94568",
      "additional_info_contact": "925-557-4353 Ext. 4458",
      "reason_for_recall": "Potential Retina Damage-- An error in the user manual may result in misapplied filter and injury during treatment.",
      "root_cause_description": "Labeling mix-ups",
      "action": "Carl Zeiss Meditec Inc sent a SAFETY ALERT letter dated May 18, 2009, via Federal Express to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.  \nCustomers were reminded to use the correct retinal protection filter (GG475) when using the OPMI VISU 200 system during ophthalmic surgery.\nVerify the position of the retinal protection filter and inform their staff of the customizable feature.  \nVerify that the correct filter was in place.  \nCustomers were asked to complete the acknowledgement form indicating receipt of the alert.  Sign and return the form to:\nCarl Zeiss Meditec in Dublin, California via the enclosed self-addressed, pre-paid Federal Express envelope.\nFor any questions customers should call (925) 557-4422.",
      "product_quantity": "2540 units",
      "distribution_pattern": "Worldwide Distribution including USA (nationwide) and the UK",
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        "device_name": "Microscope, Surgical",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4700",
        "device_class": "1"
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    }
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}