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Alcon Research LLC recalls Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
Recalled July 24, 2024 · FDA recall Z-2412-2024 · Alcon Research
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. · FDA Class II
Units
230
Sold at
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.
Description
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.
Product
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
Manufacturer(s)
Alcon Research LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →