Recall Z-2412-2024— Alcon Research LLC
Class II · Ongoing
Class II FDA medical device recall by Alcon Research LLC, initiated 2024-05-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399. 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..
- Recalling firm
- Alcon Research LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-23
- Firm location
- Fort Worth, TX, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.