STAAR Surgical AG recalled 7 EVO+ Visian TICL VTICM5 lenses after finding a labeling error that listed 12.1 mm length but which are 12.6 mm. The mismatch can cause excessive vault and ocular complications. Physicians and patients should stop using the device immediately and follow manufacturer instructions for recall actions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Staar Surgical AG or your healthcare provider for instructions. Notification method: N/A
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The EVO+ Visian TICL is a toric implantable lens used to correct myopia with astigmatism in phakic eyes. It is implanted by an ophthalmic surgeon during a cataract or refractive procedure in appropriate candidates.
A length labeling error caused the device to be longer than labeled. This can create excessive vault, leading to eyes issues and possibly requiring surgical intervention.
This recall is not part of a broader industry pattern.
Patients may require lens exchange or removal. Urgent ophthalmologic follow-up is advised for implanted patients and people awaiting implantation.
UDI-DI and serial numbers are printed on labeling and packaging; patient records will include implant details.
4-8 weeks for replacement or removal arrangements in many regions; actual surgical timelines vary by provider.
Keep recall notices, surgical records, serial numbers, and communications with providers and manufacturers.
Brand: STAAR Surgical AG Product: EVO+ Visian Toric Implantable Collamer Lens (TICL) Model: VTICM5 UDI-DI: 00840311304363 Serial Numbers: T2286964, T2286971, T2286973, T2286979, T2286980, T2286981, T2286988 Expiration Date: 2027-11-30 Quantity Recalled: 7 units Recall Date: 2026-01-21 Distributor Regions: India, Iran, Korea, Saudi Arabia Sold at: Unknown Manufacturer: STAAR Surgical AG
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