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device recall
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Staar Surgical AG device recall (Cls II)

January 21, 2026$STAAupdated 5mo ago
community read0 votes

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

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same company · ±60 days · 2

  • device pmaSTAAR Surgical Company — The EVO/EVO+ Visian Implantable Collamer Lens (ICL) (PMA supplement)Mar 4, 2026
  • device pmaSTAAR Surgical Company — Visian® Toric Implantable Collamer® Lens (TICL) (PMA supplement)Dec 10, 2025

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  • tagPMA Approval3 co-mentions · 3 sources
  • tagRecall1 co-mentions · 1 sources

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