FWJClass I

Camera, Cine, Microsurgical, Without Audio

General, Plastic Surgery · 21 CFR 878.4160

MDR events1All time

Recalls1All time

Registered firms7Currently listed

510(k) clearances0All time

Recent MDR events

1 adverse event reports on file

MICRODIGITAL IP 4.1 CAMERA HEADNov 6, 2000
MalfunctionCircon Video2020483-2000-00006

Event type breakdown

Malfunction1

Most-reported manufacturers

Recalls

1 recall events for this product code

Alcon Research LLC
Open, ClassifiedJul 18, 2024
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
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.
Z-2412-2024 · View FDA record ↗

Registered firms

7 firms currently registered for this product code

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for this product code.