🔍 RecallPedia

BostonSight SCLERAL Lens

Class I - Dangerous
🏥 Medical Devices Recalled: June 10, 2025 Boston Foundation For Sight Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Boston Foundation For Sight
Reason for Recall:
Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

BostonSight SCLERAL Lens

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2190-2025

Related Recalls

BostonSight PROSE Lens.

Boston Foundation For Sight

Class I - Dangerous

Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.

Jun 10, 2025 Other Medical Devices Nationwide View Details →