VERION REFERENCE UNIT
Received Feb 24, 2016 · Event occurred Jan 25, 2016
Report 3010300699-2016-00007 · MDR key 5459017
Device
Generic name
Keratometer, Pupillometer
Manufacturer
Wavelight Gmbh (agps)Model number
X-RUPCatalog number
8065998240
Lot number
ASKU
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence 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 SURGEON REPORTED AFTER PLANNING FOR LASER ASSISTED CATARACT SURGERY WITHOUT ARCUATES, THE DATA WAS TRANSFERRED SHOWING ARCUATES THAT COULD NOT BE TURNED OFF OR MODIFIED. THE CASES WERE COMPLETED WITHOUT THE USE OF THE PLANNING DEVICE.