CLASS II Device recall · Reported 6 Aug 2025 · FDA Enforcement Report
BostonSight Prose Lens recalled by Boston Foundation For Sight
Boston Foundation For Sight is recalling BostonSight Prose Lens, distributed nationwide in the US. The recall was initiated on 10 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2191-2025
- FDA event ID
- 97123
- Recalling firm
- Boston Foundation For Sight, Needham, MA
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 10 Jun 2025
- FDA classified
- 29 Jul 2025
- Reported
- 6 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Jun 2025 | Recall initiated by company | |
| 29 Jul 2025 | Classified by FDA | +49 days |
| 6 Aug 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Product as listed by the FDA
BostonSight PROSE Lens.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada.
Questions about this recall
Is BostonSight Prose Lens recalled?
Yes. Boston Foundation For Sight recalled BostonSight Prose Lens on 10 Jun 2025. The recall is Class II and its status is Completed. Recall number Z-2191-2025.
Why was it recalled?
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Which lots are affected?
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 Number: 534761. 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 Numbers: 535453. 5. UDI Number [Lot Number], Serial Numbers: (01)00785811435677(10)24183007 [24183007] Serial Numbers: 540811. 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 Numbers: 539865. 10. UDI Number [Lot Number], Serial Numbers: (01)00865576000218(10)F2300341 [F2300341] Serial Numbers: 535908. 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 Numbers: 540171. 13. UDI Number [Lot Number], Serial Numbers: (01)00865576000294(10)F2500408 [F2500408] Serial Numbers: 539392.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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