{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Houston",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91878",
      "recalling_firm": "Alcon Research, LLC",
      "address_1": "9965 Buffalo Speedway",
      "address_2": "N/A",
      "postal_code": "77054-1309",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: AL, AR, CA, IA, ID, IN, KY, MN, NC, ND, NJ, OH, PA, TX,  OUS: None",
      "recall_number": "Z-1291-2023",
      "product_description": "Alcon Custom Pak Surgical Procedure Pack:  Pak Number & Pak Description:  17533-04\tDR GROSS LPS LLC  18704-03\tCATARACT SURGI CARE  18382-03\tDR GEORGE ZAMBELLI BEAVER VALLEY ASC  8685-21\tCATARACT PACK EYE SURGICAL CNTR OF AR  19451-02\tDR ROESKE PACK INLAND VALLEY SURGERY CTR  19136-03\tOCCULOPLASTIC WILMINGTON EYE  18401-03\tMCGRAW SIGHTPATH MEDICAL  16032-05\tMIDDLE TENNESSEE PACK SIGHTPATH MEDICAL  17570-05\tCATARACT CENTURION FORT MADISON COMM HOS  19002-02\tCATARACT BAPTIST HEALTH SURGERY CENTER  10560-14\tCATARACT - NORTH CENTRAL 1 SIGHTPATH MED  16877-11\tDR DAVID B LEACH CLEARVIEW SURGERY CENTE  19061-02\tHOSLER UNIVERSITY SURGI CENTER  18911-02\tMASON CATARACT THE ASC AT UNITED MEDICAL  17469-02\tGENERAL CUSTOM PACK SHARP MEMORIAL HOSPI  18917-01\tCATARACT 2 SURGERY CENTER OF THE TEMECUL  17115-06\tDR SCZEPANSKI NORTH DAKOTA EYE CLINIC  17780-04\tOPHTHALMIC TEXAS PRECISION SURGERY CENTE  2452-58\tCATARACT BOLSA OUTPATIENT SURG CTR  19096-01\tOPHTHALMIC EAST ALABAMA AMB SURGERY CENT  18023-04\tOPHTHALMIC BRAINARD SURGERY CENTER  17039-13\tEYE-Q COMPLETE CAT PAK VISION CARE SURG  5300-61\tCATARACT WOODLAND MEM HOSP",
      "product_quantity": "1035 packs",
      "reason_for_recall": "Sterility; Steril surgical procedure packs contain incomplete seals.",
      "recall_initiation_date": "20230310",
      "center_classification_date": "20230328",
      "report_date": "20230405",
      "code_info": "Lot #-Pack #-Expiry Date - UDI: 158JNA 17533-04 9/30/2024       00380655132814; 158L18 18704-03 12/31/2024 00380651672833; 158JNN 18382-03 10/31/2024 00380655117132; 158L27 8685-21 09/30/2024 00380655142486; 158L24 19451-02 09/30/2024 00380655143995; 158L44 19136-03 12/31/2024 00380655129975; 158HU3 18401-03 04/30/2024 00380651651487; 158MH8 16032-05 12/31/2024 00380653369250; 158L5X 17570-05 10/31/2024 00380655129227; 158NEX 19002-02 10/31/2024 00380655120231; 158MJ3 10560-14 12/31/2024 00380655136317; 158NE8 16877-11 12/31/2024 00380655116579; 158NDK 19061-02 08/31/2024     00380655118504; 158NEM 18911-02 04/30/2024 00380651691940; 158PCP 17469-02 08/31/2024 00380653377156; 158PCD 18917-01 09/30/2024    00380651677333; 158P8K 17115-06 07/31/2024 00380651698079; 158NDC 17780-04 12/31/2024 00380651682719; 158N9Y 2452-58 12/31/2024 00380653403589; 158MFC 19096-01 10/31/2024 00380651696235; 158MHL 18023-04 10/31/2024 00380651661189; 158P7W 17039-13 08/31/2024 00380651701229; 158P97 5300-61 10/31/2024 00380651672659;"
    }
  ]
}