{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "214725",
      "product_res_number": "Z-2165-2025",
      "event_date_initiated": "2025-06-16",
      "event_date_posted": "2025-07-23",
      "recall_status": "Open, Classified",
      "res_event_number": "97173",
      "product_code": "LPM",
      "pma_numbers": [
        "P080011"
      ],
      "product_description": "Biofinity XR Toric Contact Lens",
      "code_info": "Carton Lot Numbers: RD0226792, RD0227007, RD0227022, RD0227030, RD0227032, RD0228123, RD0228336, RD0228465, RD0228570, RD0228595, RD0228598, RD0228603, RD0228606, RD0228607, RD0228775, RD0228778, RD0228788, RD0228795, RD0228798, RD0228799, RD0228802, RD0228809, RD0228814, RD0228825, RD0228835, RD0228840, RD0228842, RD0228847, RD0228853, RD0228854, RD0228855, RD0228866, RD0228875, RD0228876, RD0228940, RE0152731, RE0152735, RE0152737, RE0152740, RE0152743, RE0152744, RE0152755, RE0152760, RE0152775, RE0152799, RE0152838, RE0152871, RE0152873, RE0152877, RE0152883, RE0152889, RE0152891, RE0152913, RE0152915, RE0152917, RE0153804, RE0153819, RE0153924, RE0153974, RE0154076, RE0154085, RE0154095, RE0154100, RE0154103, RE0154105, RE0154107, RE0154113, RE0154114, RE0154117, RE0154137, RE0154139, RE0154143, RE0154253, RE0154256, RE0154259, RE0154264, RE0154271, RE0154329.",
      "firm_fei_number": "1314956",
      "recalling_firm": "CooperVision, Inc.",
      "address_1": "711 North Rd",
      "city": "Scottsville",
      "state": "NY",
      "postal_code": "14546-1238",
      "additional_info_contact": "Annette Nelson\n925-6604471",
      "reason_for_recall": "Lens blisters may have an incomplete or leaking seal which may render them unsterile.",
      "root_cause_description": "Use error",
      "action": "An URGENT MEDICAL DEVICE CORRECTION notice dated 6/27/25 was mailed to distributors, retailers, and physicians notifying them of this recall. The notification instructs consignees to inspect their inventory for affected devices and stop any further distribution/sale of affected devices. Practitioners are instructed to share the provided Consumer Communication Letter with any patients who received affected devices and to have patients return any units in their possession for replacement or credit. Consignees are to dispose of any affected product in their inventory or that is returned. Consignees are to complete and return the provided Correction Response Form via fax to 888-385-3217 or by email at info@coopervision.com. Consignees with any complaints can contact the Customer Care Team at 855-526-6737; questions about this recall action can be directed to Customer Service at 800-341-2020.",
      "product_quantity": "397 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.",
      "openfda": {
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        "device_name": "Lenses, Soft Contact, Extended Wear",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.5925",
        "device_class": "3"
      }
    }
  ]
}