Class II

Medical Device Recall: BostonSight PROSE Lens.

Boston Foundation For Sight · June 10, 2025

Reason for Recall

Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada.

States Affected

NATIONWIDE

Quantity Affected

38 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2191-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.