EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5

Recall Insight

This FDA Devices action (record #Z-1480-2026) was formally reported on March 11, 2026, with the manufacturer initiating the action on January 21, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Staar Surgical AG is listed as the recalling firm, operating out of Nidau, N/A. Federal records indicate 7 units are affected.

The documented reason for this recall is: 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:… Distribution data in the federal record shows the product reached: International distribution to the countries of India, Iran, Korea, Saudi Arabia.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. Because this recall is recent, remedy windows and replacement inventory are most likely still actively available from the firm or retailer. Always cross-check the recall number against the official agency page before relying on any summary.