Z-2172-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 14, 2017
- Initiation Date
- April 4, 2017
- Termination Date
- July 31, 2017
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 83
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Distribution
Code Information
Serial No: TR 0010, TR 0095