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  "name": "Brand Name: Alcon Laboratories, Inc.  Product Name: Accessory devices for Unity and Constellation surgical consoles  Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'  8065750918\tPAK,I/A LINE,NGVS  8065750957\tASSY,SHIP,CONSTELLATION VFC  8065750972\tENDOILLUMATOR,RFID,23G  8065751014\tCONST AUTO GAS FILL PAK  8065751014\tCONST AUTO GAS FILL PAK  8065751441\tENDOILLUMINATOR,RFID,25G  8065751577\tCHANDELIER,25GA,W/RFID    Software Version: N/A  Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console.  Component: N/A",
  "description": "FDA recall Z-0305-2026 — Alcon Research LLC is recalling Brand Name: Alcon Laboratories, Inc.  Product Name: Accessory devices for Unity and Constellation surgical consoles  Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'  8065750918\tPAK,I/A LINE,NGVS  8065750957\tASSY,SHIP,CONSTELLATION VFC  8065750972\tENDOILLUMATOR,RFID,23G  8065751014\tCONST AUTO GAS FILL PAK  8065751014\tCONST AUTO GAS FILL PAK  8065751441\tENDOILLUMINATOR,RFID,25G  8065751577\tCHANDELIER,25GA,W/RFID    Software Version: N/A  Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console.  Component: N/A (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0305-2026&lang=eng",
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    "@type": "schema:MedicalDevice",
    "name": "Brand Name: Alcon Laboratories, Inc.  Product Name: Accessory devices for Unity and Constellation surgical consoles  Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'  8065750918\tPAK,I/A LINE,NGVS  8065750957\tASSY,SHIP,CONSTELLATION VFC  8065750972\tENDOILLUMATOR,RFID,23G  8065751014\tCONST AUTO GAS FILL PAK  8065751014\tCONST AUTO GAS FILL PAK  8065751441\tENDOILLUMINATOR,RFID,25G  8065751577\tCHANDELIER,25GA,W/RFID    Software Version: N/A  Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console.  Component: N/A",
    "manufacturer": {
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      "name": "Alcon Research LLC"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0305-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0305-2026: Alcon Research LLC is recalling Brand Name: Alcon Laboratories, Inc.  Product Name: Accessory devices for Unity and Constellation surgical consoles  Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'  8065750918\tPAK,I/A LINE,NGVS  8065750957\tASSY,SHIP,CONSTELLATION VFC  8065750972\tENDOILLUMATOR,RFID,23G  8065751014\tCONST AUTO GAS FILL PAK  8065751014\tCONST AUTO GAS FILL PAK  8065751441\tENDOILLUMINATOR,RFID,25G  8065751577\tCHANDELIER,25GA,W/RFID    Software Version: N/A  Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console.  Component: N/A",
      "text": "The FDA logged enforcement record Z-0305-2026: Alcon Research LLC is voluntarily recalling Brand Name: Alcon Laboratories, Inc.  Product Name: Accessory devices for Unity and Constellation surgical consoles  Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'  8065750918\tPAK,I/A LINE,NGVS  8065750957\tASSY,SHIP,CONSTELLATION VFC  8065750972\tENDOILLUMATOR,RFID,23G  8065751014\tCONST AUTO GAS FILL PAK  8065751014\tCONST AUTO GAS FILL PAK  8065751441\tENDOILLUMINATOR,RFID,25G  8065751577\tCHANDELIER,25GA,W/RFID    Software Version: N/A  Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console.  Component: N/A — reason: Due to incomplete seals in the pouch which provide the sterile barrier.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-08-05. Affected lots/codes: Catalog Number: 8065750918 UDI-DI code:00380657509188 Lot/Batch Number: 1790L4  Catalog Number: 8065750957 UDI-DI code: 00380657509577 Lot/Batch Numbers: 1788D3 1788DC 1788D1 1790T0 179LNP 179LNT 179LNV 179LP2 179LPA 17A0P8 17A0PC 17A0PH 17C125 17CJEW 17CXT3 17D0RY 17DL3Y 17DL40 17DL41 17DL42 17DL46 17DPRT 17DPRU 17ERNK 17F2NR 17F55K  Catalog Number: 8065750972 UDI-DI code: 00380657509720 Lot/Batch Numbers: 17C8T2 17C8T4 17E0TX  Catalog Number: 8065751014 UDI-DI code: 00380657510146 Lot/Batch Numbers: 1789PV 1789PW 1788DD 1788DE 17C2MY 17C2NE 17DL3P 17DL3U 17DL3W 17DL3X 17E0WU 17E0X0 17F4D6  Catalog Number: 8065751441 UDI-DI code: 00380657514410 Lot/Batch Numbers: 17C6U5 17C359 17C35A  Catalog Number: 8065751577 UDI-DI code: 00380657515776 Lot/Batch Numbers: 1789P4 1789P5 1789P6 179MCD 17C2RV 17C2RY 17C2T3 17DPN7 17DPN8. A RECORDED FDA enforcement action (occurred=true).",
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      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
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      "name": "FDA classified recall Z-0305-2026 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
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      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
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      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
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      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
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            "Value": "Z-0305-2026",
            "Status": "recorded"
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            "Status": "recorded"
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "Alcon Research LLC",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Due to incomplete seals in the pouch which provide the sterile barrier.",
            "Status": "recorded"
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-08-05",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "Catalog Number: 8065750918 UDI-DI code:00380657509188 Lot/Batch Number: 1790L4  Catalog Number: 8065750957 UDI-DI code: 00380657509577 Lot/Batch Numbers: 1788D3 1788DC 1788D1 1790T0 179LNP 179LNT 179LNV 179LP2 179LPA 17A0P8 17A0PC 17A0PH 17C125 17CJEW 17CXT3 17D0RY 17DL3Y 17DL40 17DL41 17DL42 17DL46 17DPRT 17DPRU 17ERNK 17F2NR 17F55K  Catalog Number: 8065750972 UDI-DI code: 00380657509720 Lot/Batch Numbers: 17C8T2 17C8T4 17E0TX  Catalog Number: 8065751014 UDI-DI code: 00380657510146 Lot/Batch Numbers: 1789PV 1789PW 1788DD 1788DE 17C2MY 17C2NE 17DL3P 17DL3U 17DL3W 17DL3X 17E0WU 17E0X0 17F4D6  Catalog Number: 8065751441 UDI-DI code: 00380657514410 Lot/Batch Numbers: 17C6U5 17C359 17C35A  Catalog Number: 8065751577 UDI-DI code: 00380657515776 Lot/Batch Numbers: 1789P4 1789P5 1789P6 179MCD 17C2RV 17C2RY 17C2T3 17DPN7 17DPN8",
            "Status": "recorded"
          }
        },
        {
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "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,",
            "Status": "recorded"
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