VERION DIGITAL MARKER M
Received Aug 17, 2017 · Event occurred Jul 19, 2017
Report 3010300699-2017-00025 · MDR key 6802020
Device
Generic name
Marker, Ocular
Manufacturer
Wavelight Gmbh (agps)Model number
X-SPMCatalog number
8065998242
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
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 SURGEON REPORTED; AFTER IMPLANTATION OF THE INTRAOCULAR LENS DURING IMAGE GUIDED CATARACT SURGERY IT WAS FOUND THAT THE SYSTEM MARKER SHOWS THE IMPLANTATION AXIS AT TWO DEGREES. THE SURGEON REVIEWED THE TREATMENT PLAN AND FOUND THE AXIS SHOULD BE AT ELEVEN. AFTER REBOOT OF THE SYSTEM THE MARKER DISPLAYED THE CORRECT AXIS WHICH ALIGNED WITH THE DATA PRINT OUT. NO PATIENT HARM REPORTED.
Additional Manufacturer Narrative
NO ANOMALIES FOUND BY REVIEW OF DEVICE HISTORY RECORD. PRODUCT MET ALL SPECIFICATIONS WHEN RELEASED. BASED ON THE PROVIDED DATA COLLECTION OF THIS CASE A USER ERROR CAN BE CONFIRMED. THE INITIAL SURGICAL PLAN SHOWS THE REPORTED 11° AS IMPLANTATION AXIS. HOWEVER BASED ON THE PROVIDED DATA, ON THE PLANNING SCREEN THE IMPLANTATION AXIS WAS MANUALLY CHANGED TO 2°. ACCORDINGLY THESE 2° HAVE BEEN SHOWN DURING SURGERY AS IMPLANTATION AXIS. THE FIELD SERVICE ENGINEER WAS ON SITE AND RETRAINED THE CUSTOMER RELATING TO THESE ISSUES. (B)(4)