FDAFDA · Food and drugs·Recall number Z-2172-2017
Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) operations (laser trabeculoplasty for primary open angle glaucoma). In the VAG mode it is intended to be used to perform procedures requiring the rupture of tissue in the eye for Iridotomy and Iridectomy, Posterior capsulotomy and Posterior membranectomy.
Published June 14, 2017 · Recall initiated: April 4, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
It was discovered the unit produced a laser emission without pressing the fire button when the slit-lamp was driven to its lowest position prior to use on any patient.
What to do
FDA Mandated · Letter
Recall details
- Manufacturer
- Laserex Systems Inc.
- Distributor
- US Distribution
- Lot
- Serial No: TR 0010, TR 0095
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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