FDA Device recall Z-2412-2024

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

FDA Device
Class II
ongoing
Published 2024-07-24

On 2024-07-24 the FDA classified a Class II recall of Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399 by Alcon Research, citing after surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registra….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2412-2024
Classification	Class II
Status	ongoing
Initiated	2024-05-23
Published	2024-07-24
Last updated	2026-09-13 11:57 UTC
Company	Alcon Research
Distribution	US

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.

Identifiers

code_info	UDI-DI: 00380650003997. Software Version: 1.5. Serial Numbers: 004-0680001, 004-0680002, 004-0680003, 004-0680004, 004… 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, 0

code_info

UDI-DI: 00380650003997. Software Version: 1.5. Serial Numbers: 004-0680001, 004-0680002, 004-0680003, 004-0680004, 004…

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, 0

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2412-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.