Reported Aug 6, 2025 · Ongoing
BostonSight PROSE Lens.
Boston Foundation For Sight
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Foundation For Sight · 464 Hillside Ave Ste 205 · Needham, MA · 02494-1228
Is this the product you have?
- BostonSight PROSE Lens.
- Lot codes and dates
- 1. UDI Number [Lot Number]
- Serial Numbers(01)00785811435077(10)24341007 [24341007]
- Serial Numbers
534720536887540283. 2. UDI Number [Lot Number]
- Serial Numbers(01)00785811435639(10)20030007 [20030007]
- Serial Number534761. 3. UDI Number [Lot Number]
- Serial Numbers(01)00785811435639(10)24214004 [24214004]
- Serial Numbers
536327537399538805. 4. UDI Number [Lot Number]
- Serial Numbers(01)00785811435677(10)22078002 [22078002]
- Serial Numbers535453. 5. UDI Number [Lot Number]
- Serial Numbers(01)00785811435677(10)24183007 [24183007]
- Serial Numbers540811. 6. UDI Number [Lot Number]
- Serial Numbers(01)00865576000201(10)F2402477 [F2402477]
- Serial Numbers
532389532390532660532666532816533417533418533419533420. 7. UDI Number [Lot Number]
- Serial Numbers(01)00865576000201(10)F2403286 [F2403286]
- Serial Numbers
534129534130535028535029535711535712535869536897537916537918538203. 8. UDI Number [Lot Number]
- Serial Numbers(01)00865576000201(10)F2403377 [F2403377]
- Serial Numbers
533357533358. 9. UDI Number [Lot Number]
- Serial Numbers(01)00865576000201(10)T020007 [)T020007]
- Serial Numbers539865. 10. UDI Number [Lot Number]
- Serial Numbers(01)00865576000218(10)F2300341 [F2300341]
- Serial Numbers535908. 11. UDI Number [Lot Number]
- Serial Numbers(01)00865576000294(10)F2402750 [F2402750]
- Serial Numbers
532817534107536034. 12. UDI Number [Lot Number]
- Serial Numbers(01)00865576000294(10)F2403018 [F2403018]
- Serial Numbers540171. 13. UDI Number [Lot Number]
- Serial Numbers(01)00865576000294(10)F2500408 [F2500408]
- Serial Numbers539392
- Amount recalled
- 38 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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