{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Santa Ana",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88564",
      "recalling_firm": "Johnson & Johnson Surgical Vision Inc",
      "address_1": "1700 E Saint Andrew Pl",
      "address_2": "",
      "postal_code": "92705-4933",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide distribution in the state of IL.",
      "recall_number": "Z-0028-2022",
      "product_description": "TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag.  The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile, disposable insertion system for delivering the IOL into the eye during cataract surgery.",
      "product_quantity": "1 lens",
      "reason_for_recall": "Nonconforming product was distributed in error.  Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended endotoxin specification limit.  Product was released in error based on the results of additional testing performed during the investigation into release testing nonconformance.",
      "recall_initiation_date": "20210806",
      "center_classification_date": "20211004",
      "termination_date": "20230306",
      "report_date": "20211013",
      "code_info": "Model: DIU225U050 UDI Code: (01)05050474745831(17)240414(21)5248142104 Production Order Number: 900001985625 Serial Number: 5248142104",
      "more_code_info": ""
    }
  ]
}