Boston Foundation For Sight recalls BostonSight PROSE Lens.

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

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 LVillers@Bostonsight.org or by phone at 781-726-7436.

• FDA enforcement recordOfficial FDA database entry for Z-2191-2025
• FDA 510(k) clearance · K161461The device's official FDA premarket clearance record
• FDA device classification · HQDOfficial FDA classification for this device type
• CFR regulation · 21 CFR 886.5916The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Boston Foundation For SightSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.