FDAMay 23, 2024device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

alcon researchalcon

UPCs

00380650003997

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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