{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "214613", "product_res_number": "Z-2190-2025", "event_date_initiated": "2025-06-10", "event_date_posted": "2025-07-29", "recall_status": "Completed", "res_event_number": "97123", "product_code": "HQD", "k_numbers": [ "K183175" ], "product_description": "BostonSight SCLERAL Lens", "code_info": "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.\n\n2. UDI Number [Lot Number], Serial Numbers: (01)00785811435639(10)24159006 [24159006] Serial Number: 532311.\n\n3. UDI Number [Lot Number], Serial Numbers: (01)00785811435639(10)24214004 [24214004] Serial Numbers: 533233, 533327, 533329, 533685, 534355, 535382, 535656, 536029, 536645. \n\n4. 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. \n\n5. UDI Number [Lot Number], Serial Numbers: (01)00785811435677(10)24183007 [24183007] Serial Numbers: 534853, 535050, 535386, 535468, 536080, 536893. \n\n6. UDI Number [Lot Number], Serial Numbers: (01)00785811435677(10)24270004 [24270004] Serial Numbers: 533000, 533015, 533158, 533291, 533292. \n\n7. UDI Number [Lot Number], Serial Numbers: (01)00865576000201(10)F2402477 [F2402477] Serial Numbers: 531283, 531284, 532900, 532975, 533241. \n\n8. 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. \n\n9. 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. \n\n10. 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. \n\n11. 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. \n\n12. UDI Number [Lot Number], Serial Numbers: (01)00865576000201(10)F2500351 [F2500351] Serial Numbers: 537344. \n\n13. UDI Number [Lot Number], Serial Numbers: (01)00865576000218(10)F2000255 [F2000255] Serial Numbers: 533111, 533245, 533773, 534049, 534084, 534213, 536907. \n\n14. UDI Number [Lot Number], Serial Numbers: (01)00865576000218(10)F2203214 [F2203214] Serial Numbers: 532833, 532841, 533614, 533615, 533616, 533617, 533618, 533620, 533621, 533622. \n\n15. UDI Number [Lot Number], Serial Numbers: (01)00865576000218(10)F2300341 [F2300341] Serial Numbers: 533735, 535512. \n\n16. 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. \n\n17. 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. \n\n18. 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. \n\n19. 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. \n\n20. 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. \n\n21. 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. \n\n22. UDI Number [Lot Number], Serial Numbers: (01)00865576000294(10)F2500408 [F2500408] Serial Numbers: 532828, 532831, 536432, 536433, 536827, 537061.", "firm_fei_number": "3006204913", "recalling_firm": "Boston Foundation For Sight", "address_1": "464 Hillside Ave Ste 205 464 Hillside Ave", "address_2": "Ste 205", "city": "Needham", "state": "MA", "postal_code": "02494-1228", "additional_info_contact": "Paul Piselli\n781-675-9943", "reason_for_recall": "Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.", "root_cause_description": "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 LVillers@Bostonsight.org or by phone at 781-726-7436.", "product_quantity": "441 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada.", "openfda": { "k_number": [ "K162005", "K991780", "K051035", "K201194", "K022128", "K942365", "K002845", "K990264", "K071266", "K171575", "K940277", "K071043", "K962934", "K070637", "K103561", "K053124", "K170335", "K952165", "K153066", "K970698", "K033594", "K000485", "K170007", "K221768", "K955366", "K952260", "K060102", "K241571", "K120996", "K161461", "K991781", "K183175", "K024164", "K013310", "K233325", "K000795", "K223394", "K021977", "K010454", "K180616", "K102154", "K960584", "K180988", "K213538", "K113586", "K021752", "K033599", "K242393", "K180172", "K160938", "K241398", "K153714", "K170001", "K943784", "K000133", "K073184", "K172314", "K052507", "K963512", "K993586", "K980741", "K841163", "K083921", "K202860", "K212631", "K213880", "K052675", "K963010", "K163254", "K011914", "K142510", "K152724", "K942533", "K081178", "K161100", "K972443", "K052983", "K230965", "K081034", "K013646", "K962006", "K002703", "K081443", "K171077", "K203571", "K945955", "K941883", "K974636", "K171950", "K002025", "K954124", "K011945", "K001960", "K183167", "K230910", "K990895", "K020006", "K013762", "K240618", "K955900", "K984436", "K181579", "K840115", "K944223", "K943177", "K070628", "K082799", "K061120", "K980197", "K171404", "K003932", "K080193", "K992787", "K062548", "K963744", "K253822", "K000233", "K182304" ], "pma_number": [ "P890072", "N17878", "P890058", "P860022", "P840055", "P890046", "P900001", "P820074", "P880024", "P880001", "P820056", "P790010", "P920045", "P880041", "P820062", "P890044", "P880098", "P840050", "P880035", "P850038", "P870024" ], "registration_number": [ "3043365583", "1720959", "3005087645", "3022320387", "3033524682", "1065845", "3010607087", "2031102", "3001190611", "1000123221", "2030598", "3002830597", "9612500", "3014964775", "1835957", "3025308027", "3014175039", "3020246591", "3032010300", "9614761", "3003357577", "9681630", "3012719596", "3005147469", "3005994941", "1281950", "3045320731", "3003062331", "1123818", "3012228452", "3013398957", "1313525", "3014769028", "3006204913", "3022988037" ], "fei_number": [ "3043365583", "1720959", "1317628", "3005087645", "3022320387", "3033524682", "2017777", "3010607087", "3001190611", "1000123221", "3002807465", "3002830597", "3014964775", "1000188353", "3025308027", "3014175039", "3020246591", "1000305478", "3032010300", "3003357577", "3012719596", "3003040707", "3002340631", "3005147469", "3005994941", "1281950", "1000518731", "3045320731", "3003062331", "3012228452", "3013398957", "3014769028", "3002808845", "3006204913", "3022988037" ], "device_name": "Lens, Contact (Other Material) - Daily", "medical_specialty_description": "Ophthalmic", "regulation_number": "886.5916", "device_class": "2" } } ] }