FDA Medical devices recall ·
BostonSight PROSE Lens recall
- Recall number
- Z-2191-2025
- Date
- (initiated June 10, 2025)
- Company / brand
- Boston Foundation For Sight
464 Hillside Ave Ste 205, Needham, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Completed
- Units affected
- 38 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BostonSight PROSE Lens.
Why was it recalled?
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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] Ser
Distribution
Worldwide distribution - US Nationwide and the countries of Canada.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2191-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.