{
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  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1368-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery.  Model Number:  LCS1500UNOL  LCS1800UNST  LCS4K00UNOL  LCS1530BTOL  LCS1830BTST  LCS4K30BTOL  LCS1530TPOL  LCS1830TPST  LCS4K30TPOL  LCS1545BTOL  LCS1845BTST  LCS4K45BTOL  LCS1545TPOL  LCS1845TPST  LCS4K45TPOL  LCS1570BTOL  LCS1870BTST  LCS4K70BTOL  LCS1570TPOL  LCS1870TPST  LCS4K70TPOL",
  "description": "FDA recall Z-1368-2024 — Olympus Corporation of the Americas is recalling InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery.  Model Number:  LCS1500UNOL  LCS1800UNST  LCS4K00UNOL  LCS1530BTOL  LCS1830BTST  LCS4K30BTOL  LCS1530TPOL  LCS1830TPST  LCS4K30TPOL  LCS1545BTOL  LCS1845BTST  LCS4K45BTOL  LCS1545TPOL  LCS1845TPST  LCS4K45TPOL  LCS1570BTOL  LCS1870BTST  LCS4K70BTOL  LCS1570TPOL  LCS1870TPST  LCS4K70TPOL (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.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1368-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery.  Model Number:  LCS1500UNOL  LCS1800UNST  LCS4K00UNOL  LCS1530BTOL  LCS1830BTST  LCS4K30BTOL  LCS1530TPOL  LCS1830TPST  LCS4K30TPOL  LCS1545BTOL  LCS1845BTST  LCS4K45BTOL  LCS1545TPOL  LCS1845TPST  LCS4K45TPOL  LCS1570BTOL  LCS1870BTST  LCS4K70BTOL  LCS1570TPOL  LCS1870TPST  LCS4K70TPOL",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Olympus Corporation of the Americas"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1368-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1368-2024: Olympus Corporation of the Americas is recalling InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery.  Model Number:  LCS1500UNOL  LCS1800UNST  LCS4K00UNOL  LCS1530BTOL  LCS1830BTST  LCS4K30BTOL  LCS1530TPOL  LCS1830TPST  LCS4K30TPOL  LCS1545BTOL  LCS1845BTST  LCS4K45BTOL  LCS1545TPOL  LCS1845TPST  LCS4K45TPOL  LCS1570BTOL  LCS1870BTST  LCS4K70BTOL  LCS1570TPOL  LCS1870TPST  LCS4K70TPOL",
      "text": "The FDA logged enforcement record Z-1368-2024: Olympus Corporation of the Americas is voluntarily recalling InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery.  Model Number:  LCS1500UNOL  LCS1800UNST  LCS4K00UNOL  LCS1530BTOL  LCS1830BTST  LCS4K30BTOL  LCS1530TPOL  LCS1830TPST  LCS4K30TPOL  LCS1545BTOL  LCS1845BTST  LCS4K45BTOL  LCS1545TPOL  LCS1845TPST  LCS4K45TPOL  LCS1570BTOL  LCS1870BTST  LCS4K70BTOL  LCS1570TPOL  LCS1870TPST  LCS4K70TPOL — reason: Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consistency globally, the Japanese IFU will be updated to reflect the instructions in the English IFU. Status: Ongoing — the recall is still being carried out.. Initiated 2024-01-16. Affected lots/codes: UDI-DI: N/A All Lot Numbers. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1368-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1368-2024&lang=eng"
        }
      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1368-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1368-2024 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1368-2024&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1368-2024&lang=eng"
        }
      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1368-2024/boundary",
      "@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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "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."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1368-2024",
      "numberOfItems": 9,
      "itemListElement": [
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1368-2024",
            "Status": "recorded"
          }
        },
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          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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        },
        {
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Olympus Corporation of the Americas",
            "Status": "recorded"
          }
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consistency globally, the Japanese IFU will be updated to reflect the instructions in the English IFU",
            "Status": "recorded"
          }
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-01-16",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "UDI-DI: N/A All Lot Numbers",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "International distribution to the country of Japan.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}