FDA recall Z-2191-2025
Boston Foundation For Sight · Class II · device
Product
BostonSight PROSE Lens.
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.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-06-10
- Report date
- 2025-08-06
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Needham, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2191-2025