VERION DIGITAL MARKER M
Received Apr 21, 2016 · Event occurred Mar 3, 2016
Report 3010300699-2016-00017 · MDR key 5596685
Device
Generic name
Marker, Ocular
Manufacturer
Wavelight Gmbh (agps)Model number
X-SPMCatalog number
8065998243
Lot number
ASKU
Product problems
- Malposition of Device
Patient
Not reported
- No Code Available
- No Code Available
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. (B)(4).
Description of Event or Problem
A DOCTOR REPORTED THAT TORIC INTRAOCULAR LENS IMPLANTED IN A PATIENT'S RIGHT EYE WAS MISALIGNED BY 90 DEGREES ONE DAY POST CATARACT SURGERY. DIAGNOSTIC IMAGING SYSTEM WAS USED DURING THE IMPLANTATION. AT ONE DAY FOLLOW UP, PATIENT WAS TAKEN BACK INTO THE OPERATING ROOM AND LENS WAS REPOSITIONED.
Additional Manufacturer Narrative
NO ANOMALIES WERE FOUND BY REVIEW OF DEVICE HISTORY RECORD. THE PRODUCT MET ALL SPECIFICATIONS WHEN RELEASED. THERE ARE TWO POSSIBLE SCENARIOS FOR ROOT CAUSES FOR A ROTATED LENS BY 90 DEGREES WHICH ARE BOTH USE ERRORS. AN INCORRECT DOCTOR SEATING POSITION SELECTION MAY RESULT IN A WRONG DISPLAYED AXIS SHOWN IN THE OVERLAY - USE ERROR. THE SECOND SCENARIO IS THAT THE USER HAS SELECTED THE SIMPLIFIED OVERLAY WHICH SHOWS ONLY THE STEEP AND FLAT AXIS. THE USER THEN MIGHT HAVE ORIENTED THE LENS ACCORDING THE WRONG AXIS SHOWN IN THE OVERLAY - USE ERROR. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).