Alcon Research LLC: Device Recall

Recall #Z-2412-2024 · 05/23/2024

Class II: Risk

Recall Details

Recall Number
Z-2412-2024
Classification
Class II
Product Type
Device
Recalling Firm
Alcon Research LLC
Status
Ongoing
Date Initiated
05/23/2024
Location
Fort Worth, TX, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
230

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.

Product Description

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

Distribution Pattern

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.

Other Recalls by Alcon Research LLC

View all recalls by Alcon Research LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.