BEUDAMED
    FDA Enforcement Class II Ongoing

    BostonSight PROSE Lens.

    Recall: Z-2191-2025 · Reported August 6, 2025

    Enforcement

    Recall Number
    Z-2191-2025
    Event ID
    97123
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Foundation For Sight
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 6, 2025
    Initiation Date
    June 10, 2025
    Classification Date
    July 29, 2025
    Address
    464 Hillside Ave Ste 205, Needham, MA, 02494-1228, United States

    Description

    BostonSight PROSE Lens.

    Reason

    Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.

    Code Info

    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.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada.

    Quantity

    38 units