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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2190-2025

BostonSight SCLERAL Lens

Publicado el 6 de agosto de 2025 · Inicio del retiro: 10 de junio de 2025

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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

Qué hacer

Voluntary: Firm initiated · E-Mail

Detalles del retiro

Fabricante
Boston Foundation For Sight
Distribuidor
Worldwide distribution - US Nationwide and the countries of Canada.
Lote
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
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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