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Completed

BostonSight PROSE Lens.

FDA Recall Z-2191-2025 · Posted 2025-07-29

Recalling FirmBoston Foundation For Sight
Recall StatusCompleted
Product CodeHQD
Date Initiated2025-06-10
Product Quantity38 units

Reason for Recall

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

Firm 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.

Root Cause

Process control

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K161461BostonSight PD Prosthetic DeviceBostonsight · 2016-07-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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