FDA Device recall Z-2191-2025
BostonSight PROSE Lens
- FDA Device
- Class II
- completed
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of BostonSight PROSE Lens by Boston Foundation For Sight, citing select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2191-2025 |
| Classification | Class II |
| Status | completed |
| Initiated | 2025-06-10 |
| Published | 2025-08-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Foundation For Sight |
| Distribution | US |
Product
BostonSight PROSE Lens.
Reason
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Identifiers
| code_info | 1. UDI Number [Lot Number], Serial Numbers: (01)00785811435077(10)24341007 [24341007] Serial Numbers: 534720, 536887, 5…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2191-2025%22
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