BostonSight SCLERAL Lens — Class II medical device recall Z-2190-2025
Completed recall by Boston Foundation For Sight, reported 2025-08-06, distributed nationwide. Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
| Recall number | Z-2190-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Foundation For Sight, Needham, MA, United States |
| Recall initiated | 2025-06-10 |
| Classified | 2025-07-29 |
| Reported by FDA | 2025-08-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 441 units |
| UPC / GTIN / UDI-DI | 00785811435639, 00785811435677, 00865576000201, 00865576000218, 00865576000294 |
| Serial numbers | 527131, 527418, 529303, 529304, 529720, 531283, 531284, 531633, 532283, 532304, 532311, 532321, 532329, 532330, 532334, 532344, 532357, 532359, 532368, 532370, 532388, 532391, 532393, 532406, 532413 and 416 more |
Product
BostonSight SCLERAL Lens
Reason for recall
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2190-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.