VERION DIGITAL MARKER M FOR LEICA MICROSCOPES
Received Nov 10, 2014 · Event occurred Oct 17, 2014
Report 3010300699-2014-00008 · MDR key 4280320
Device
Generic name
Camera, Still, Microsurgical
Manufacturer
Wavelight Gmbh (agps)Model number
X-SPMCatalog number
8065998242
Lot number
NA
Product problems
- Display or Visual Feedback Problem
Patient
65 YR
- 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 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. ADD'L INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).
Description of Event or Problem
A SURGEON REPORTED THAT DURING INTRAOCULAR LENS (IOL) ALIGNMENT TO THE VERTICAL AXIS, THE DIGITAL MARKER INDICATED A SECOND VERTICAL AXIS AT 20-30 DEGREES. THIS EVENT WAS REPORTED TO HAVE BEEN OBSERVED TWICE. NO PT HARM WAS REPORTED. ADD'L INFO HAS BEEN REQUESTED, BUT NOT RECEIVED TO DATE.