| | Class 2 Device Recall BostonSight SCLERAL |  |
| Date Initiated by Firm | June 10, 2025 |
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| Date Posted | July 29, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2191-2025 |
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| Recall Event ID |
97123 |
| 510(K)Number | K161461 |
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| Product Classification |
Lens, contact (other material) - daily - Product Code HQD
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| Product | BostonSight PROSE Lens. |
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| Code Information |
1. UDI Number [Lot Number], Serial Numbers: (01)00785811435077(10)24341007 [24341007] Serial Numbers: 534720, 536887, 540283.
2. UDI Number [Lot Number], Serial Numbers: (01)00785811435639(10)20030007 [20030007] Serial Number: 534761.
3. UDI Number [Lot Number], Serial Numbers: (01)00785811435639(10)24214004 [24214004] Serial Numbers: 536327, 537399, 538805.
4. UDI Number [Lot Number], Serial Numbers: (01)00785811435677(10)22078002 [22078002] Serial Numbers: 535453.
5. UDI Number [Lot Number], Serial Numbers: (01)00785811435677(10)24183007 [24183007] Serial Numbers: 540811.
6. UDI Number [Lot Number], Serial Numbers: (01)00865576000201(10)F2402477 [F2402477] Serial Numbers: 532389, 532390, 532660, 532666, 532816, 533417, 533418, 533419, 533420.
7. UDI Number [Lot Number], Serial Numbers: (01)00865576000201(10)F2403286 [F2403286] Serial Numbers: 534129, 534130, 535028, 535029, 535711, 535712, 535869, 536897, 537916, 537918, 538203.
8. UDI Number [Lot Number], Serial Numbers: (01)00865576000201(10)F2403377 [F2403377] Serial Numbers: 533357, 533358.
9. UDI Number [Lot Number], Serial Numbers: (01)00865576000201(10)T020007 [)T020007] Serial Numbers: 539865.
10. UDI Number [Lot Number], Serial Numbers: (01)00865576000218(10)F2300341 [F2300341] Serial Numbers: 535908.
11. UDI Number [Lot Number], Serial Numbers: (01)00865576000294(10)F2402750 [F2402750] Serial Numbers: 532817, 534107, 536034.
12. UDI Number [Lot Number], Serial Numbers: (01)00865576000294(10)F2403018 [F2403018] Serial Numbers: 540171.
13. UDI Number [Lot Number], Serial Numbers: (01)00865576000294(10)F2500408 [F2500408] Serial Numbers: 539392.
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| FEI Number |
3006204913
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Recalling Firm/
Manufacturer |
Boston Foundation For Sight
464 Hillside Ave Ste 205
Needham MA 02494-1228
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| For Additional Information Contact | Paul Piselli
781-675-9943 |
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Manufacturer Reason
for Recall | Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both. |
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FDA Determined
Cause 2 | Process control |
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| 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. |
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| Quantity in Commerce | 38 units |
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| Distribution | Worldwide distribution - US Nationwide and the countries of Canada. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = HQD
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