{
  "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": "2026-06-24",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Anasco",
      "state": "PR",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "98402",
      "recalling_firm": "AMO Puerto Rico Manufacturing, Inc.",
      "address_1": "Rd # 402 North Km 4.2, Industrial Park",
      "address_2": "",
      "postal_code": "00610",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S Nationwide distribution in the states of CA,FL, IL, ME,MS, NJ, NY, OK, OR, TX, and WI.",
      "recall_number": "Z-1634-2026",
      "product_description": "Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity\" Delivery System  Product Name: TECNIS Eyhance IOL with TECNIS Simplicity\" Delivery System  Model/Catalog Number: DIB00  Software Version: N/A  Product Description: The TECNIS SIMPLICITY\" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY\" Delivery System Model DIB00 contains the TECNISEyhance\" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY\" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye.  Component: No",
      "product_quantity": "361",
      "reason_for_recall": "Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.",
      "recall_initiation_date": "20260219",
      "center_classification_date": "20260324",
      "report_date": "20260401",
      "code_info": "Lot Code: GTIN: 05050474731776 SKU: DIB00U0210-12 Serial Numbers: 2409342403 2410072403 2409612403 2409692403 2409752403 2891682403 2891132403 2892032403 2531882403 2531902403 2531212403 2530842403 2531242403 2531892403 2531622403",
      "more_code_info": ""
    }
  ]
}