Recall Z-2190-2025— Boston Foundation For Sight

Name: FDA recall Z-2190-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-10

Class II · Ongoing

Class II FDA medical device recall by Boston Foundation For Sight, initiated 2025-06-10. It names one FDA 510(k) clearance: K183175. Product: BostonSight SCLERAL Lens. Reason: Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both..

Recalling firm: Boston Foundation For Sight
Classification: Class II
Status: Ongoing
Initiated: 2025-06-10
Firm location: Needham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K183175 — BostonSight ScleralBostonsight·cleared 2019-01-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BostonSight SCLERAL Lens

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.