Staar Surgical recalls EVO+ Visian Toric Implantable Collamer Lenses (VTICM5) that are 12.6mm instead of 12.1mm, potentially causing eye damage. Affected lenses have specific serial numbers and expiration dates.
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.
Staar Surgical is recalling EVO+ Visian Toric Implantable Collamer Lenses (model VTICM5) because they are 12.6mm instead of the labeled 12.1mm. This size difference could cause excessive eye vault, leading to reduced corneal angles, increased eye pressure, and discomfort. Patients should contact the manufacturer for lens exchange.
The lenses are labeled as 12.1mm but are actually 12.6mm, creating a larger space between the lens and the eye. This can narrow the eye's front chamber, increase pressure, and cause discomfort or vision issues.
Patients who received the EVO+ Visian Toric Implantable Collamer Lens (VTICM5) model with serial numbers T2286964 through T2286988. Those with pre-existing eye conditions like astigmatism are at higher risk.
Check for serial numbers T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, or T2286988 on the lens packaging. The expiration date is November 30, 2027.
Reach out to Staar Surgical for lens exchange or removal if you have the recalled model.
The lenses are labeled as 12.1mm but are actually 12.6mm, which can cause excessive eye vault, reducing corneal angles and increasing eye pressure.
Contact Staar Surgical directly to arrange for lens exchange or removal.
Yes, the recalled lenses have serial numbers T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, or T2286988.
We’ve drafted a message you can send Staar Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-1480-2026 — Staar Surgical Staar Surgical Hello, I own a Staar Surgical that is covered by recall Z-1480-2026 from Staar Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
