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  "name": "EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5",
  "description": "FDA recall Z-1480-2026 — Staar Surgical AG is recalling EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 (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": "EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5",
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      "name": "FDA recall Z-1480-2026: Staar Surgical AG is recalling EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5",
      "text": "The FDA logged enforcement record Z-1480-2026: Staar Surgical AG is voluntarily recalling EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 — reason: Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, Unreactive pupil, Lens exchange/removal.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-01-21. Affected lots/codes: UDI-DI: 00840311304363. Expiration Date: 2027-11-30 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1480-2026 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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      "@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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            "Field": "Reason",
            "Value": "Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, Unreactive pupil, Lens exchange/removal.",
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            "Value": "International distribution to the countries of India, Iran, Korea, Saudi Arabia.",
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