BostonSight SCLERAL Lens recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models 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.

Product

BostonSight SCLERAL Lens

Recalling firm

Boston Foundation For Sight

Quantity

441 units

Distribution

Worldwide distribution - US Nationwide and the countries of Canada.

Recall date

August 6, 2025

Classification

Class II

Status

Completed

Agency

FDA (device)