{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
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  },
  "results": [
    {
      "cfres_id": "198326",
      "product_res_number": "Z-1197-2023",
      "event_date_initiated": "2023-01-26",
      "event_date_posted": "2023-03-01",
      "recall_status": "Open, Classified",
      "res_event_number": "91607",
      "product_code": "LPM",
      "pma_numbers": [
        "P080011"
      ],
      "product_description": "Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)",
      "code_info": "UDI: N/A\nLot Numbers:\nR24377024, R24377026, R24381716, R24416900",
      "firm_fei_number": "3005724763",
      "recalling_firm": "CooperVision, Inc.",
      "address_1": "180 Thruway Park Dr",
      "city": "West Henrietta",
      "state": "NY",
      "postal_code": "14586-9798",
      "additional_info_contact": "SAME\n585-756-9300",
      "reason_for_recall": "Manufactured with misaligned axis resulting in\nlenses with the incorrect power, users may experience poor visual acuity",
      "root_cause_description": "Employee error",
      "action": "Coopervision issued Urgent Medical Device Correction letter on 1/26/23 to direct consignees requesting end users be notified. Letter states reason for recall, health risk and action to take:\nPlease examine your inventory/product shelf for any of the provided affected lot numbers.\nThe lot number can be found on the back panel of the carton below the expiration date.\nBelow is an example and where to locate the lot number.\n\" Stop any further distribution of product from the designated lot numbers;\n\" We recommend you contact your Eye Care Practitioners or patients who have received the affected product. Please instruct Eye Care Practitioners or patients to return any affected\nproduct to you for replacement or credit.\n\" Enclosed you will find a template that can be customized by the ECP for distribution to\ntheir patients.\n\nPlease note that if a credit is due to you, this will automatically be applied to your account once we have received and validated your  Correction Response Form . This action is being reported to applicable health authorities and CooperVision may be required to identify any consignees that do not respond.\nShould you wish to discuss this action, please contact your business development\nmanager or our customer services team at: 800-341-2020, 9:00 AM   7:00 PM ET, Monday  \nFriday.",
      "product_quantity": "24 units",
      "distribution_pattern": "US Nationwide distribution in the states of CA, OH, NC, PA.",
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        ],
        "device_name": "Lenses, Soft Contact, Extended Wear",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.5925",
        "device_class": "3"
      }
    }
  ]
}