FDAFDA · Food and drugs·Recall number Z-1331-2024
Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)
Published March 27, 2024 · Recall initiated: January 15, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
- Distributor
- US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH, SC, TX and PR.
- Lot
- Product Number: 7223.ALC; UDI/DI: 08717872014173; All lots starting with a number between 2470 and 18705.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Netherlands
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