VERION REFERENCE UNIT
Received Feb 26, 2016 · Event occurred Jan 14, 2016
Report 3010300699-2016-00008 · MDR key 5463064
Device
Generic name
Keratometer, Pupillometer
Manufacturer
Wavelight Gmbh (agps)Model number
X-RUPCatalog number
8065998240
Lot number
ASKU
Product problems
- Device Remains Activated
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
NO ANOMALIES FOUND BY REVIEW OF DEVICE HISTORY RECORD. PRODUCT MET ALL SPECIFICATIONS WHEN RELEASED. AN INTERNAL INVESTIGATION HAS BEEN INITIATED BY THE MANUFACTURER FOR THIS REPORTED ISSUE. SOFTWARE FUNCTIONALITY IS UNDER REVIEW, FOR PLANNING OF TREATMENT OF NON-COMPANY MANUFACTURED LENSES, TO UNDERSTAND THE INTRODUCTION OF UNINTENDED ARCUATE/LIMBAL RELAXING INCISIONS BY WAY OF INADVERTENT ACTIVATION OF A FUNCTION WHEN USER CLICKS DEDICATED ITEMS IN TREATMENT PLANNING. (B)(4)
Description of Event or Problem
A TECHNICIAN REPORTED AFTER PULLING UP THE PLAN ON THE SYSTEM PRIOR TO LASER ASSISTED CATARACT SURGERY, THE PLAN HAD ARCUATES THAT COULD NOT BE TURNED OFF. THE CASE WAS COMPLETED CONVENTIONALLY AND WITHOUT INCIDENT.