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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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
The lenses were labeled 12.1 mm but measure 12.6 mm. This length discrepancy can create excessive vault. Excessive vault may reduce iridocorneal angles and shallow the anterior chamber. Other potential effects include patient discomfort, elevated intraocular pressure and angle-closure risk. Pupil response may be affected and lens exchange or removal could be required.
1. Stop using the device immediately. 2. Contact STAAR Surgical AG or your healthcare provider for instructions. 3. Follow all recall guidance issued by the manufacturer and regulatory authorities. 4. If you have questions, consult your ophthalmologist to determine next steps and any need for replacement or removal.
Manufacturer contact and recall specifics are provided by the FDA enforcement report. For immediate guidance, contact STAAR Surgical AG through their official channels or consult your surgeon. Patient-specific remediation will depend on clinical assessment.
Not sure what to do next? Our guide walks you through the process step by step.
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