Device product
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.
Z-2172-2017
Product summary
- Event
- Event 77170
- Status
- Terminated
- Classification
- Class II
- Quantity
- 83
- Official record key
device-enforcement:Z-2172-2017
Official wording
Reason: 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.
Code information: Serial No: TR 0010, TR 0095
Distribution pattern: US Distribution
Derived failure modes
-
Unknown
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.