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

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 230 Lot/code info: 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, 007-4610

UPC codes

00380650003997

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.