Recall archive / FDA device enforcement
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399 — FDA record Z-2412-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 23, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Alcon Research LLC
- Quantity
- 230
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2412-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 24, 2024
- Recall initiation date
- May 23, 2024
- Center classification date
- Jul 18, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.