Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
Publicado el 24 de julio de 2024 · Inicio del retiro: 23 de mayo de 2024
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
After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registration angle, range indicator will display incorrectly, which could result in incorrect placement of toric IOL axis, which could cause astigmatic error under/over correction resulting in decreased uncorrected visual acuity.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Alcon Research LLC
- Distribuidor
- Worldwide - US Nationwide distribution including in the states of AL, AR, CA, CO, CT, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, TN, TX, WA, WI, PR and the countries of Canada, Japan, France.
- Lote
- UDI-DI: 00380650003997. Software Version: 1.5. Serial Numbers: 004-0680001, 004-0680002, 004-0680003, 004-0680004, 004-0680007, 004-0680008, 004-0680017, 004-0680026, 004-0680036, 004-0680047, 004-0680048, 004-0680086, 004-0680090, 004-0680092, 004-0680096, 004-0680100, 004-0680107, 004-0680112, 004-0680120, ,004-0680127,004-0680131, 004-0680134, 004-0680140, 004-0680152, 004-0680153, 004-0680161, 004-0680163, 004-0680188, 004-0680190,004-0680203, 004-0680206, 004-0680266, 004-0680267, 004-0680271, 004-0680273, 004-0680274, 004-0680283, 004-0680288, 004-0680293, 004-0680294, 004-0680306, 004-0680311, 004-0680315, 004-0680319, 004-0680325, 004-0680334, 004-0680336, 004-0680337, 004-0680338, 004-0680339, 004-0680346, 004-0680348, 004-0680352, 004-0680362, 004-0680404, 004-0680417, 004-0680418, 005-7230003, 005-7230005, 005-7230007, 005-7230017, 005-7230019, 005-7230021, 005-7230022, 005-7230023, 005-7230031, 005-7230035, 005-7230057, 005-7230081, 005-7230085, 005-7230086, 005-7230102, 005-7230108, 005-7230109, 005-7230186, 007-4610018, 007-4610023, 007-4610030, 007-4610032, 007-4610033, 007-4610034, 007-4610037, 007-4610044, 007-4610074, 007-4610107, 007-4610112, 007-4610115, 007-4610122, 007-4610123, 007-4610124, 007-4610125, 007-4610127, 007-4610132, 007-4610138, 007-4610166, 007-4610167, 007-4610179, 007-4610181, 007-4610186, 007-4610217, 007-4610219, 007-4610220, 007-4610226, 007-4610229, 007-4610230, 007-4610262, 007-4610275, 007-4610283, 007-4610287, 007-4610288, 007-4610308, 007-4610309, 007-4610351, 007-4610355, 007-4610359, 007-4610360, 007-4610366, 007-4610394, 007-4610404, 007-4610405, 007-4610406, 007-4610409, 009-4570001, 009-4570004, 009-4570005, 009-4570007, 009-4570013, 009-4570014, 009-4570015, 009-4570016, 009-4570019, 009-4570022, 009-4570033, 009-4570035, 009-4570044, 009-4570047, 009-4570048, 009-4570049, 009-4570051,009-4570052, 009-4570053, , 009-4570054,009-4570057, 009-4570059, 009-4570060, 009-4570064, 009-4570068, 009-4570070, 009-4570072, 009-4570073, 009-4570096, 009-4570097, 009-4570099, 009-4570100, 009-4570114, 009-4570116, 009-4570125, 009-4570127, 009-4570129, 009-4570130, 009-4570136, 009-4570137, 009-4570144, 009-4570148, 009-4570149, 009-4570150, 009-4570153, 009-4570155, 009-4570156, 009-4570158, 009-4570160, 009-4570161, 009-4570167, 009-4570171, 009-4570173, 009-4570176,009-4570178, 009-4570179, 009-4570180, 009-4570183, 009-4570184, 009-4570200, 009-4570204, 009-4570207, 009-4570233, 009-4570249, 009-4570256, 009-4570259, 009-4570263, 009-4570270, 009-4570275, 009-4570278, 009-4570281, 009-4570289, 009-4570293, 009-4570294, 009-4570300, 009-4570308, 009-4570317, 009-4570320, 009-4570331, 009-4570342, 009-4570343, 009-4570350, 009-4570353, 009-4570357, 009-4570365, 009-4570368, 009-4570393, 009-4570397, 009-4570425, 009-4570431, 009-4570435, 009-4570440, 009-4570448, 009-4570449, 009-4570451, 009-4570455, 009-4570457, 009-4570459, 009-4570460, 009-4570474, 009-4570489, 009-4570508, 009-4570510, DM550021, DM550024, DM550043, DM550051, DM550054
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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