FDA-Device2025-08-06Class II
BostonSight PROSE Lens.
Boston Foundation For Sight
Hazard
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada.
Affected count
38 units
Manufactured in
464 Hillside Ave Ste 205, Needham, MA, United States
Products
BostonSight PROSE Lens.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2191-2025Don't want to check this manually?
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