# FDA recall Z-1480-2026

> **Staar Surgical AG** · Class II · device recall initiated 2026-01-21.

## Product

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

## Reason for recall

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.

## Distribution

International distribution to the countries of India, Iran, Korea, Saudi Arabia.

## Key facts

- **Recall number:** Z-1480-2026
- **Recalling firm:** Staar Surgical AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-21
- **Report date:** 2026-03-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Nidau, N/A, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1480-2026

## Citation

> AI Analytics. FDA recall Z-1480-2026. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1480-2026. Source: US FDA. Licensed CC0.

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