CLASS II Device recall · Reported 6 Aug 2025 · FDA Enforcement Report
BostonSight Scleral Lens recalled by Boston Foundation For Sight
Boston Foundation For Sight is recalling BostonSight Scleral Lens, distributed nationwide in the US. The recall was initiated on 10 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2190-2025
- FDA event ID
- 97123
- Recalling firm
- Boston Foundation For Sight, Needham, MA
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 10 Jun 2025
- FDA classified
- 29 Jul 2025
- Reported
- 6 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Jun 2025 | Recall initiated by company | |
| 29 Jul 2025 | Classified by FDA | +49 days |
| 6 Aug 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Product as listed by the FDA
BostonSight SCLERAL Lens
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada.
Questions about this recall
Why was it recalled?
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Which lots are affected?
1. UDI Number [Lot Number], Serial Numbers: (01)00785811435077(10)24341007 [24341007] Serial Numbers: 533161, 533366, 534227, 534270, 534852, 535467, 535738, 536062, 536078, 536201, 536463, 536661. 2. UDI Number [Lot Number], Serial Numbers: (01)00785811435639(10)24159006 [24159006] Serial Number: 532311. 3. UDI Number [Lot Number], Serial Numbers: (01)00785811435639(10)24214004 [24214004] Serial Numbers: 533233, 533327, 533329, 533685, 534355, 535382, 535656, 536029, 536645. 4. UDI Number [Lot Number], Serial Numbers: (01)00785811435677(10)24043010 [24043010] Serial Numbers: 532344, 532388, 532505, 532770, 532996, 533075, 533240, 533400, 533415, 533488, 534201, 534368. 5. UDI Number [Lot Number], Serial Numbers: (01)00785811435677(10)24183007 [24183007] Serial Numbers: 534853, 535050, 535386, 535468, 536080, 536893. 6. UDI Number [Lot Number], Serial Numbers: (01)00785811435677(10)24270004 [24270004] Serial Numbers: 533000, 533015, 533158, 533291, 533292. 7. UDI Number [Lot Number], Serial Numbers: (01)00865576000201(10)F2402477 [F2402477] Serial Numbers: 531283, 531284, 532900, 532975, 533241. 8. UDI Number [Lot Number], Serial Numbers: (01)00865576000201(10)F2403286 [F2403286] Serial Numbers: 533201, 533597, 533598, 533736, 533805, 533806, 534082, 534131, 534132, 534248, 534249, 534912, 534998, 534999, 535022, 535084, 535185, 536175, 536179, 536203, 536740, 537148. 9. UDI Number [Lot Number], Serial Numbers: (01)00865576000201(10)F2403377 [F2403377] Serial Numbers: 529720, 532304, 532321, 532329, 532330, 532357, 532359, 532370, 532391, 532393, 532519, 532520, 532557, 532589, 532648, 532670, 532677, 532790, 532824, 532853, 532878, 532889, 532910, 532925, 532970, 532984, 533063, 533130, 533342, 533361, 533372, 533374, 533401, 533537, 533553, 533588, 533607, 533700, 533862, 533876, 533891, 533906, 533930, 533964, 533989, 533993, 533994, 534026, 534029, 534108, 534121, 534149, 534161, 534163, 534171, 534180, 534231, 534239, 534240, 534267, 534269, 534276, 534287, 534304, 534332, 534382, 534421, 534451, 534452, 534476, 534516, 534536, 534537, 534588, 534590, 534591, 534606, 534613, 534614, 534616, 534617, 534649, 534709, 534710, 534716, 534718, 534848, 534873, 534874, 534981, 535013, 535098, 535137, 535138, 535145, 535182, 535196, 535318, 535328, 535335, 535347, 535351, 535372, 535455, 535459, 535945, 535947, 535963, 535965, 535967, 535977, 536009, 536066, 536070, 536105, 536138, 536178, 536222, 536223, 536429, 536669, 536771, 536772, 537001, 537028. 10. UDI Number [Lot Number], Serial Numbers: (01)00865576000201(10)F2500084 [F2500084] Serial Numbers: 531633, 532283, 532334, 532368, 532503, 532583, 532662, 532675, 532700, 532731, 532732, 532741, 532886, 532891, 532930, 532944, 532983, 533080, 533085, 533175, 533227, 533434, 533436, 533464, 533466, 533484, 533662, 533714, 533715, 533738, 533793, 533835, 533856, 534667, 534776, 534889, 534993, 535174, 535176, 535316, 535370, 535406, 535407. 11. UDI Number [Lot Number], Serial Numbers: (01)00865576000201(10)F2500102 [F2500102] Serial Numbers: 527131, 535133, 535413, 535501, 535609, 535610, 535734, 535735, 535813, 535814, 535828, 535834, 535982, 535983, 536001, 536071, 536111, 536143, 536145, 536229, 536299, 536455, 536472, 536604, 536726, 536728, 536871, 536872, 536923. 12. UDI Number [Lot Number], Serial Numbers: (01)00865576000201(10)F2500351 [F2500351] Serial Numbers: 537344. 13. UDI Number [Lot Number], Serial Numbers: (01)00865576000218(10)F2000255 [F2000255] Serial Numbers: 533111, 533245, 533773, 534049, 534084, 534213, 536907. 14. UDI Number [Lot Number], Serial Numbers: (01)00865576000218(10)F2203214 [F2203214] Serial Numbers: 532833, 532841, 533614, 533615, 533616, 533617, 533618, 533620, 533621, 533622. 15. UDI Number [Lot Number], Serial Numbers: (01)00865576000218(10)F2300341 [F2300341] Serial Numbers: 533735, 535512. 16. UDI Number [Lot Number], Serial Numbers: (01)00865576000218(10)F2301495 [F2301495] Serial Numbers: 532888, 533495, 533534, 533612, 533754, 533920, 534037, 534041, 534058, 534060, 534092, 534095, 534146, 534157, 534158. 17. UDI Number [Lot Number], Serial Numbers: (01)00865576000218(10)F2402189 [F2402189] Serial Numbers: 532640, 533502, 533613, 533619, 534929, 534930, 534933, 534934, 534936, 534951, 534952, 535134, 535153, 535724, 535725, 535728, 535775, 535776, 535788, 535789, 535796, 535827, 535829, 535830, 535929, 536031, 536079, 536081, 536711, 536713, 536714. 18. UDI Number [Lot Number], Serial Numbers: (01)00865576000218(10)F2402243 [F2402243] Serial Numbers: 534279, 534280, 534424, 534507, 534624, 534634, 534636, 534637, 534638, 534639, 534641, 534642, 535122, 535727, 535771, 535772, 535773, 535964, 536257, 536809. 19. UDI Number [Lot Number], Serial Numbers: (01)00865576000294(10)F2402750 [F2402750] Serial Numbers: 527418, 533310, 533313, 533477, 533653, 534242, 534411, 534621, 534824, 535020, 535096, 535241, 535559, 535648, 535649, 536137, 536716, 536929, 536933, 536959, 536964, 536965, 536966, 537062. 20. UDI Number [Lot Number], Serial Numbers: (01)00865576000294(10)F2403494 [F2403494] Serial Numbers: 532559, 532564, 532758, 532811, 532901, 532903, 532935, 532953, 533344, 533375, 533918, 534895, 536387, 536465, 536466, 536698, 536862. 21. UDI Number [Lot Number], Serial Numbers: (01)00865576000294(10)F2500310 [F2500310] Serial Numbers: 529303, 529304, 532406, 532413, 532416, 532600, 532602, 532624, 532759, 532780, 532868, 532897, 533054, 533056, 533156, 533194, 533567, 533708, 533866, 533884, 533922, 533955, 534218, 534219, 534345, 534367, 534375, 534390, 534492, 534740, 534742, 534810, 534893, 535278, 535342, 535497, 535715, 536035, 536380. 22. UDI Number [Lot Number], Serial Numbers: (01)00865576000294(10)F2500408 [F2500408] Serial Numbers: 532828, 532831, 536432, 536433, 536827, 537061.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97123| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | BostonSight Prose Lens recalled by Boston Foundation For Sight | Boston Foundation For Sight | Other | Nationwide |
More recalls from Boston Foundation For Sight
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | BostonSight Prose Lens recalled by Boston Foundation For Sight | Boston Foundation For Sight | Other | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |