HJMClass II

Transilluminator, Ac-powered

Ophthalmic · 21 CFR 886.1945

MDR events7All time

Recalls3All time

Registered firms12Currently listed

510(k) clearances12All time

Recent MDR events

7 adverse event reports on file

Event type breakdown

Injury5

Malfunction2

Most-reported manufacturers

Chiu Technical Corp1 Infinitech, Inc.1 Lumitex1 Lumitex Md, Inc1 Ohmeda Medical1 Sylvan Corporation1 Venoscope1

Recalls

3 recall events for this product code

Vortex Surgical Inc.
Open, ClassifiedFeb 4, 2026
Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
XXX
Z-1254-2026 · View FDA record ↗
Chiu Technical Corp
TerminatedJan 9, 2008
Transilluminator, Model BFO-150, a Fiber Optic Light Source (Illuminator), available in 2 voltages: 115v for USA users & 220v for foreign countries. --- Chiu Te
Device was marketed without a 510(k).
Z-0320-2008 · View FDA record ↗
Bausch & Lomb Inc
TerminatedDec 24, 2003
CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes.
The CX9625 Light Pipe connector may overheat; this condition could result in the plastic connector that plugs into the Millennium Microsurgical System to malfunction.
Z-0264-04 · View FDA record ↗

Registered firms

12 firms currently registered for this product code

510(k) clearances

12 clearances for this product code