Class II

Medical Device Recall: BostonSight SCLERAL 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

441 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2190-2025

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.

Boston Foundation For Sight Medical Device Recall: BostonSight SCLERAL Lens | SafeCheck