Recall Z-2412-2024 ยท FWJ Camera, Cine, Microsurgical, Without Audio
Alcon Research LLC
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
| Date | Jul 18, 2024 (initiated May 23, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 registrati |
| Quantity | 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 and the countries of Canada, Japan, France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.