Boston Foundation For Sight: Device Recall

Recall #Z-2191-2025 · 06/10/2025

Class II: Risk

Recall Details

Recall Number: Z-2191-2025
Classification: Class II
Product Type: Device
Recalling Firm: Boston Foundation For Sight
Status: Ongoing
Date Initiated: 06/10/2025
Location: Needham, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 38 units

Reason for Recall

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

Product Description

BostonSight PROSE Lens.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada.

Other Recalls by Boston Foundation For Sight

Class II: Risk 06/10/2025

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

View all recalls by Boston Foundation For Sight →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.