FDA recall Z-1480-2026

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

Status

Ongoing

Initiation date

2026-01-21

Report date

2026-03-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Nidau, N/A, Switzerland

Primary source

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