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Alcon Research LLC Recall 94848

Description: Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399

Alcon Research LLC Recall 94848 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2412-2024
Event ID94848
Event DescriptionSurgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
Product TypeDevices
DistributionWorldwide - 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.
Quantity230
Recall ReasonAfter 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.
Device Classification20240724
Device Code InfoUDI-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
Center Classification Date20240718
Recall Initiation Date20240523
Recalling FirmAlcon Research LLC
Initial Notification Letter
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