Alcon Research LLC Recall: Surgical Image Guidance Functionality, software used with NGENU
Alcon Research LLC Recall: Surgical Image Guidance Functionality, software used with NGENU is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Alcon Research LLC; Product: Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399; R
| Recalling firm | Alcon Research LLC |
|---|---|
| Product | Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399 |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| 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. |
| Recall initiated | 20240523 |
| Recall number | Z-2412-2024 |
| Category | device |
| State | TX |
| Country | United States |
$29/mo
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