Medical device recalls Moderate risk

Boston Foundation For Sight recalls BostonSight SCLERAL Lens

Recall date
June 10, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2190-2025
FDA classification
Class II
Brand / firm
Boston Foundation For Sight
Sold / distributed
Worldwide distribution - US Nationwide and the countries of Canada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BostonSight SCLERAL Lens

Get recall alerts

Free email alert whenever Boston Foundation For Sight has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Boston Foundation For Sight