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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1634-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity\" Delivery System  Product Name: TECNIS Eyhance IOL with TECNIS Simplicity\" Delivery System  Model/Catalog Number: DIB00  Software Version: N/A  Product Description: The TECNIS SIMPLICITY\" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY\" Delivery System Model DIB00 contains the TECNISEyhance\" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY\" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye.  Component: No",
  "description": "FDA recall Z-1634-2026 — AMO Puerto Rico Manufacturing, Inc. is recalling Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity\" Delivery System  Product Name: TECNIS Eyhance IOL with TECNIS Simplicity\" Delivery System  Model/Catalog Number: DIB00  Software Version: N/A  Product Description: The TECNIS SIMPLICITY\" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY\" Delivery System Model DIB00 contains the TECNISEyhance\" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY\" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye.  Component: No (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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    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1634-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity\" Delivery System  Product Name: TECNIS Eyhance IOL with TECNIS Simplicity\" Delivery System  Model/Catalog Number: DIB00  Software Version: N/A  Product Description: The TECNIS SIMPLICITY\" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY\" Delivery System Model DIB00 contains the TECNISEyhance\" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY\" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye.  Component: No",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "AMO Puerto Rico Manufacturing, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1634-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1634-2026: AMO Puerto Rico Manufacturing, Inc. is recalling Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity\" Delivery System  Product Name: TECNIS Eyhance IOL with TECNIS Simplicity\" Delivery System  Model/Catalog Number: DIB00  Software Version: N/A  Product Description: The TECNIS SIMPLICITY\" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY\" Delivery System Model DIB00 contains the TECNISEyhance\" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY\" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye.  Component: No",
      "text": "The FDA logged enforcement record Z-1634-2026: AMO Puerto Rico Manufacturing, Inc. is voluntarily recalling Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity\" Delivery System  Product Name: TECNIS Eyhance IOL with TECNIS Simplicity\" Delivery System  Model/Catalog Number: DIB00  Software Version: N/A  Product Description: The TECNIS SIMPLICITY\" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY\" Delivery System Model DIB00 contains the TECNISEyhance\" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY\" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye.  Component: No — reason: Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-02-19. Affected lots/codes: Lot Code: GTIN: 05050474731776 SKU: DIB00U0210-12 Serial Numbers: 2409342403 2410072403 2409612403 2409692403 2409752403 2891682403 2891132403 2892032403 2531882403 2531902403 2531212403 2530842403 2531242403 2531892403 2531622403. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
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        "supported": true,
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        "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-1634-2026&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-1634-2026&lang=eng"
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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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1634-2026/fda-classification",
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      "name": "FDA classified recall Z-1634-2026 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class II",
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          "name": "U.S. FDA recall classification (openFDA enforcement)",
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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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1634-2026/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": {
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        "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."
    }
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      "name": "FDA recall details — Z-1634-2026",
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            "Value": "Z-1634-2026",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "item": {
            "Field": "Recalling firm",
            "Value": "AMO Puerto Rico Manufacturing, Inc.",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2026-02-19",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "Lot Code: GTIN: 05050474731776 SKU: DIB00U0210-12 Serial Numbers: 2409342403 2410072403 2409612403 2409692403 2409752403 2891682403 2891132403 2892032403 2531882403 2531902403 2531212403 2530842403 2531242403 2531892403 2531622403",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S Nationwide distribution in the states of CA,FL, IL, ME,MS, NJ, NY, OK, OR, TX, and WI.",
            "Status": "recorded"
          }
        }
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}