Alcon recalls specific software for NGENUITY 3D Visualization System (part 8065000399) due to potential incorrect IOL axis placement after eye surgery. Affected units have serial numbers listed in the 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.
Alcon is recalling a specific software component used with their NGENUITY 3D Visualization System. If eye movement occurs during surgery, the software may display incorrect registration angles, potentially causing improper IOL placement and vision issues.
After surgery, if the patient's eye moves significantly during image guidance, the software may reset to an incorrect registration angle. This could lead to improper alignment of the IOL (intraocular lens) axis, causing vision errors that might require additional correction.
Surgical patients who have received the recalled software version (1.5) for the NGENUITY 3D Visualization System. Surgeons using this software with the affected serial numbers are most at risk.
Check if your NGENUITY 3D Visualization System software has serial numbers listed in the recall (e.g., 004-0680001, 004-0680002, etc.). The software version is 1.5. The part number is 8065000399.
Verify your software version is 1.5 by checking the device settings or documentation.
Reach out to Alcon directly to confirm if your specific serial number is affected and get instructions.
The recall indicates a potential risk of incorrect IOL placement if eye movement occurs during surgery, but it does not state that injuries have occurred.
Check if your serial number is listed in the recall (e.g., 004-0680001, 004-0680002, etc.) and if your software version is 1.5.
The recall does not specify a stop-use action; it only lists affected serial numbers and software version.
We’ve drafted a message you can send Alcon to request your refund or repair — edit it as you like.
Subject: Recall Z-2412-2024 — Alcon Alcon Hello, I own a Alcon that is covered by recall Z-2412-2024 from Alcon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
