BEUDAMED
    FDA Recall Open, Classified

    BostonSight SCLERAL Lens

    Recall: Z-2190-2025 · Initiated June 10, 2025

    Recall

    Recall Number
    Z-2190-2025
    Event Number
    97123
    Firm
    Boston Foundation For Sight
    FEI Number
    3006204913
    Product Code
    HQD
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 10, 2025
    Posted
    July 29, 2025
    Address
    464 Hillside Ave, Ste 205, Needham, MA, 02494-1228

    Description

    BostonSight SCLERAL Lens

    Reason

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

    Action

    Consignees were notified via email with the subject "URGENT: BostonSight SCLERAL- Recall of Selected Orders". Consignees are to return affected devices to BostonSight via the prepaid envelopes that are to be provided. Replacement units will be provided, and the firm will be in contact with information regarding replacements. Consignees with any questions are to contact Laurel Villers by email at [email protected] or by phone at 781-726-7436.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada.

    Quantity

    441 units