Staar Surgical EVO+ Visian Toric implant recalled for incorrect lens size
What this means
Staar Surgical EVO+ Visian Toric Implantable Collamer Lenses (Model VTICM5) were labeled as 12.1 mm but are actually 12.6 mm in length. The larger size can cause the lens to sit too high in the eye, potentially reducing eye drainage and increasing eye pressure, which may lead to discomfort, vision problems, or the need for lens removal.
- If you received this lens implant, contact your eye doctor immediately
- Your doctor can assess whether your lens matches the labeled size and monitor for symptoms like eye discomfort or vision changes
- Ask your doctor about the serial number of your implant to confirm if it is affected
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1480-2026Want us to check the next one for you?
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