Z-2190-2025Class II

BostonSight SCLERAL Lens

Name: Z-2190-2025 BostonSight SCLERAL Lens
Creator: Boston Foundation For Sight
Published: 2025-06-10
License: https://open.fda.gov/license/

BOSTON FOUNDATION for SIGHT/BostonSight TECH / initiated 2025-06-10 / Open, Classified / root cause: manufacturing process

FDA source

Boston Foundation For Sight began a recall of BostonSight SCLERAL Lens on 2025-06-10. FDA classified it as Class II and gives the reason as "Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2190-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-10
Posted: 2025-07-29
Recalling firm: BOSTON FOUNDATION for SIGHT/BostonSight TECH
Product: BostonSight SCLERAL Lens
Product code: HQD Lens, Contact (Other Material) - Daily
Reason for recall: Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
Root cause tag: manufacturing process
FDA root cause: Process control
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 [email protected] or by phone at 781-726-7436.
Quantity in commerce: 441 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2190-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2190-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-29
Z-2191-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-29

Product code HQD

K183175Class IIBostonSight ScleralBostonsight / cleared 2019-01-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)