Class II — Boston Foundation For Sight
| Recalling firm | Boston Foundation for Sight |
|---|---|
| Registered facility | BOSTON FOUNDATION FOR SIGHT/BostonSight TECH (the firm's only registered facility) |
| Classification | Class II |
| Status | Completed |
| Reason | Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both. |
| Product | BostonSight SCLERAL Lens |
| Quantity | 441 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada. |
| Initiated | 2025-06-10 |
| Classified | 2025-07-29 |
| Recall number | Z-2190-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Boston Foundation For Sight (Z-2190-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97123/
Alerts for Boston Foundation for Sight
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.