Recall Z-2191-2025 ยท HQD Lens, Contact (Other Material) - Daily
Boston Foundation For Sight
BostonSight PROSE Lens.
| Date | Jul 29, 2025 (initiated Jun 10, 2025) |
| Status | Completed |
| Reason | Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both. |
| Root cause | Process control |
| 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 LVillers@Bostonsight.org or by phone at 781-726-7436. |
| Quantity | 38 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161461 | BostonSight PD Prosthetic Device Bostonsight, Jul 25, 2016 |