Needham, MA, United States
Boston Foundation For Sight recalls
1 recall recorded since 2018, most recently on 10 June 2025. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Completed Class II Medical devices
- Recall started
- 10 June 2025
- Reason
- Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2190-2025, Z-2191-2025
- BostonSight SCLERAL Lens
- BostonSight PROSE Lens.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.