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  "name": "Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)",
  "description": "FDA recall Z-1332-2024 — D.O.R.C. Dutch Opthalmic Research Center Intl B.V. is recalling Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm) (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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      "name": "FDA recall Z-1332-2024: D.O.R.C. Dutch Opthalmic Research Center Intl B.V. is recalling Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)",
      "text": "The FDA logged enforcement record Z-1332-2024: D.O.R.C. Dutch Opthalmic Research Center Intl B.V. is voluntarily recalling Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm) — reason: When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the  laser fiber tip precisely.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-01-15. Affected lots/codes: Product Number: 7225.ALC; UDI/DI: 08717872014203; All lots starting with a number between 2470 and 18705.. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1332-2024 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.",
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      "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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            "Field": "Distribution pattern",
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