BostonSight PROSE Lens.
FDA device recall Z-2191-2025 · posted 2025-07-29 · Open, Classified
Recall details
- Recalling firm
- Boston Foundation For Sight
- Reason for recall
- Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HQD
- Quantity affected
- 38 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada.
- Date initiated
- 2025-06-10
- Date posted
- 2025-07-29
- Location
- Needham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BostonSight PD Prosthetic Device (K161461) | Bostonsight | 2016-07-25 |