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

FDA device recall Z-2412-2024 · posted 2024-07-18 · Open, Classified

Recall details

Recalling firm

Alcon Research LLC

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.

Action taken

On 5/23/24, correction notices were mailed to customers informing them of the following: Prior to ending procedure, re-perform registration to ensure proper axis alignment. Firm is expediting a software update that is expected to be released to upgrade systems running on software version 1.5 starting mid-June 2024. Firm's Technical Service representative will contact you to schedule your service appointment for this software upgrade. If you choose to use the image guidance functionality for toric alignment, to mitigate the potential for this anomaly, users are advised to re-perform registration prior to ending the case or if any axis discrepancy is noted during the case. To re-perform registration, go to the registration step, re-confirm the reference image to the new surgery image, adjust the registration angle (if necessary), select "Confirm" and proceed to toric alignment or desired step. Complete and return the response form via email to Market.Actions@Alcon.com If you have any questions regarding this issue, please contact your Firm representative or Technical Support at 1-800-832-7827 or contact your local Sales Representative.

Root cause

Software design

Status

Open, Classified

Product code

FWJ

Quantity affected

230

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

Date initiated

2024-05-23

Date posted

2024-07-18

Location

Fort Worth, TX