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
    • 534720
    • 536887
    • 540283. 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
    • 536327
    • 537399
    • 538805. 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
    • 532389
    • 532390
    • 532660
    • 532666
    • 532816
    • 533417
    • 533418
    • 533419
    • 533420. 7. UDI Number [Lot Number]
  • Serial Numbers(01)00865576000201(10)F2403286 [F2403286]
  • Serial Numbers
    • 534129
    • 534130
    • 535028
    • 535029
    • 535711
    • 535712
    • 535869
    • 536897
    • 537916
    • 537918
    • 538203. 8. UDI Number [Lot Number]
  • Serial Numbers(01)00865576000201(10)F2403377 [F2403377]
  • Serial Numbers
    • 533357
    • 533358. 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
    • 532817
    • 534107
    • 536034. 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.