{
  "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": "189006",
      "product_res_number": "Z-0028-2022",
      "event_date_initiated": "2021-08-06",
      "event_date_created": "2021-10-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-03-06",
      "res_event_number": "88564",
      "product_code": "MJP",
      "pma_numbers": [
        "P980040S117"
      ],
      "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.",
      "code_info": "Model: DIU225U050\nUDI Code: (01)05050474745831(17)240414(21)5248142104\nProduction Order Number: 900001985625\nSerial Number: 5248142104",
      "firm_fei_number": "3003843509",
      "recalling_firm": "Johnson & Johnson Surgical Vision Inc",
      "address_1": "1700 E Saint Andrew Pl",
      "city": "Santa Ana",
      "state": "CA",
      "postal_code": "92705-4933",
      "additional_info_contact": "Jodi Turpin-Swindle\n949-480-7526",
      "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.",
      "root_cause_description": "Process control",
      "action": "On 08/18/2021, the firm sent via FedEx standard overnight an \"URGENT DEVICE Recall\" Letter informing customers that it inadvertently release of nonconforming product (high endotoxin levels).\n\nCustomers are instructed to:\n1. Complete and return the Customer Reply Form to acknowledge receipt of the \nRecall Notice and email to RegCompliOne@its.jnj.com within 3 business days of receipt of the recall notice.\n2. Review their patient records to confirm implantation of the impacted lens.\n3. If no unexpected postoperative outcome occurred following implantation, no further action is required after Customer Reply Form has been returned.\n4. If issues were encountered, inform the Recall Firm by calling 877-266-4543, Option 2.  If reporting a complaint, provide the serial number, the date of surgery, a description of the event, and patient outcome.\n\nFor any questions, contact Customer Support at; 877-266-4543, Option 2 or email RegCompliOne@its.jnj.com",
      "product_quantity": "1 lens",
      "distribution_pattern": "U.S. Nationwide distribution in the state of IL.",
      "openfda": {
        "pma_number": [
          "P910056",
          "P980040",
          "P030002",
          "P880091"
        ],
        "registration_number": [
          "1119279",
          "3012304651",
          "1281950",
          "3015456951",
          "1313525",
          "3014173684",
          "3002807314",
          "1119421",
          "9614546",
          "3007530141",
          "9681121",
          "2023826",
          "3012236936",
          "3017636737",
          "3010155661",
          "1610287",
          "9612169",
          "2031928",
          "2648035"
        ],
        "fei_number": [
          "1119279",
          "3012304651",
          "1281950",
          "3015456951",
          "3014173684",
          "3002936283",
          "3002807314",
          "3002808262",
          "1119421",
          "3007530141",
          "3002807944",
          "1317628",
          "2023826",
          "3012236936",
          "3004651700",
          "3017636737",
          "3010155661",
          "1610287",
          "2648035"
        ],
        "device_name": "Lens, Intraocular, Toric Optics",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.3600",
        "device_class": "3"
      }
    }
  ]
}