VERION DIGITAL MARKER M
Received Jul 28, 2017
Report 3010300699-2017-00020 · MDR key 6750608
Device
Generic name
Marker, Ocular
Manufacturer
Wavelight Gmbh (agps)Model number
X-SPMCatalog number
8065998244
Lot number
00380659982446
Product problems
- Mechanical Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
REVIEW OF SURGERY DATA SHOWS THAT FLIPPING AXIS IS DUE TO THE CHANGE IN STEP FROM INCISION STEP DIRECTLY TO TORIC IMPLANTATION STEP IN THE DIGITAL MARKER M. AS THE CLINIC MOVED FROM INCISION STEP WITH THE STEEP AXIS TO THE TORIC STEP THE IMPLANTATION AXIS WAS SHOWN IN AS THE OVERLAY WHICH WAS SET TO 172 DEGREES. THE IMPLANTATION AXIS IS NOT JUMPING AS MENTIONED IN THE COMPLAINT. IT IS JUST THE CHANGE IN THE STEPS WHICH RESULTS IN DISPLAYING DIFFERENT AXIS. THE DEVICE DOES MEET ITS SPECIFICATIONS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Additional Manufacturer Narrative
INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem
A DOCTOR REPORTED THERE IS OCCASIONALLY A JUMP IN AXIS BY ABOUT 30 DEGREES. UPON FOLLOW UP, SURGERIES ALL WENT WELL AND WERE COMPLETED. NO PATIENT HARM WAS REPORTED. THE PHYSICIAN DECIDED THE CORRECT SETTING FOR THE AXIS. THERE ARE TWO RELATED REPORTS. THIS REPORT ADDRESSES THE OCCASIONALLY OCCURRENCES AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE (B)(6) 2017 EVENT.
Additional Manufacturer Narrative
NO ANOMALIES FOUND BY REVIEW OF DEVICE HISTORY RECORD. PRODUCT MET ALL SPECIFICATIONS WHEN RELEASED. USE ERROR WHICH WAS CAUSED BY A MISUNDERSTANDING BETWEEN THE LOCAL CLINICAL APPLICATIONS SPECIALIST (CAS) AND THE SURGEON WHICH COULD BE CLARIFIED WITH A RE-TRAINING. ADDITIONALLY, THE DATA ANALYSIS SHOWED INAPPROPRIATE REFERENCE AND SURGERY IMAGE USED FOR REGISTRATION ON THE SYSTEM WHICH THE CAS WILL RE-TRAIN THE SITE ON HOW TO FOLLOW THE INSTRUCTIONS CORRECTLY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Additional Manufacturer Narrative
(B)(4)
Description of Event or Problem
UPON ADDITIONAL FOLLOW UP, THE NURSE INFORMED THAT THE LAST SETTING OF THE AXIS WAS 170°. IT WAS NOT REPRODUCIBLE FOR NURSE WHETHER THIS SETTING WAS MADE MANUALLY OR WHETHER IT WAS A DEFAULT SETTING.