{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "215537",
      "product_res_number": "Z-0304-2026",
      "event_date_initiated": "2025-08-05",
      "event_date_posted": "2025-10-24",
      "recall_status": "Open, Classified",
      "res_event_number": "97415",
      "product_code": "MLZ",
      "k_numbers": [
        "K141065",
        "K233876",
        "K242184"
      ],
      "product_description": "Brand Name: Alcon Laboratories, Inc.\nProduct Name: Accessory devices for Unity and Constellation surgical consoles\nModel/Catalog Number: Many - See 'Attachment 1 - Affected Product List'\n8065000250\tUNITY 27+DS HYPERVIT 30K VIT PROBE\n8065753168\tUNITY 25+ 7.5K ANTERIOR VIT PROBE\n8065753179\tUNITY 25+ HYPERVIT 30K VIT PROBE\nSoftware Version: N/A\nProduct Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console.\nComponent: N/A",
      "code_info": "Catalog Number: 8065000250\nUDI-DI code: 00380650002501\nLot/Batch Numbers:\n17E6P1\n17E77V\n\nCatalog Number: 8065753168\nUDI-DI code: 00380657531684\nLot/Batch Number: 17EKTW\n\nCatalog Number: 8065753179\nUDI-DI code: 00380657531790\nLot/Batch Number: 17E33N",
      "firm_fei_number": "1610287",
      "recalling_firm": "Alcon Research LLC",
      "address_1": "6201 South Fwy",
      "city": "Fort Worth",
      "state": "TX",
      "postal_code": "76134-2099",
      "additional_info_contact": "Kristen Kellerhals\n1-817-5514047",
      "reason_for_recall": "Due to incomplete seals in the pouch which provide the sterile barrier.",
      "root_cause_description": "Process control",
      "action": "On 08/05/2025, the firm sent via FedEx Overnight an \"URGENT: MEDICAL DEVICE RECALL\" Letter to customers informing them that for the Alcon Standalone Vitrectomy Consumables, there is potential for some pouches within impacted lots to have an incomplete seal.\n\nCustomers are instructed to:\nlocate and dispose of any affected lots of Alcon Standalone Vitrectomy Consumables remaining in your inventory. To comply with this Medical Device Recall and request the replacement of any unused product, please take the following steps:\n1. Review inventory to determine if there are any unused affected product within their facility. See table on page 1 for affected Standalone Vitrectomy Consumable lots shipped to your location.\n2. Segregate and dispose of any unused affected product from their inventory.\n3. Call Alcon Customer Service to arrange for replacement of the affected inventory of Alcon Standalone Vitrectomy Consumables.\n4. Respond to Alcon indicating understanding of these instructions even if they have zero (0) units remaining in inventory by completing the online response form at https://qrco.de/Vit-Seal or by completing and returning the attached Response Form and returning to Alcon via email: Market.Actions@Alcon.com or fax: 817-302-4337.\n5. Forward this notification to all departments within their organization who may be in possession of this affected product; and any other organization to which this product may have been transferred.\n\nFor questions contact, Alcon Customer Service at 1-800-862-5266 or an Alcon Sales Representative.",
      "product_quantity": "577",
      "distribution_pattern": "Worldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC,SD,TN, TX, VA, WA, WI,  and WV; and OUS (foreign) to countries of: Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil,  Brunei, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Kosovo, Luxembourg, Malaysia, Mexico, Moldova, Montenegro, Morocco, Netherlands, New Zealand, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom,",
      "openfda": {
        "k_number": [
          "K220030",
          "K093305",
          "K170520",
          "K081681"
        ],
        "registration_number": [
          "3010291427",
          "2028159",
          "1650907",
          "3005012805",
          "2126666",
          "3033485955",
          "1649518",
          "1319660",
          "3015456951",
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          "2935428",
          "2953359",
          "2523835",
          "3010047402",
          "9681572",
          "3012123033",
          "3023125126",
          "3008692839",
          "1644019",
          "1928237",
          "3003398873",
          "3029973819",
          "3010208880"
        ],
        "fei_number": [
          "3010291427",
          "3001236277",
          "3005012805",
          "2126666",
          "3033485955",
          "3002681132",
          "3015456951",
          "3012236936",
          "1000221463",
          "1000136478",
          "3002807111",
          "2523835",
          "1000125771",
          "3010047402",
          "3012123033",
          "1000117501",
          "3023125126",
          "3008692839",
          "3000215205",
          "1928237",
          "3003263857",
          "3003398873",
          "3029973819",
          "3010208880"
        ],
        "device_name": "Vitrectomy, Instrument Cutter",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.4150",
        "device_class": "2"
      }
    }
  ]
}