VERION DIGITAL MARKER M FOR ZEISS MICROSCOPES
Received Jul 31, 2014
Report 3010300699-2014-00001 · MDR key 4016851
Device
Generic name
Camera, Still, Microsurgical
Manufacturer
Wavelight Gmbh AgpsModel number
X-SPMCatalog number
80659998244
Lot number
NA
Product problems
- Display or Visual Feedback Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
AN OPTHALMIC SURGEON REPORTED THAT THE MICROSCOPE DIGITAL MARKINGS WERE "DANCING" OR "JUMPING" DURING INTRAOCULAR LENS (IOL) IMPLANT IN SEVERAL PATIENTS. THE DIGITAL MARKING WERE USED IN PARALLEL WITH MANUAL MARKINGS AND DURING SURGERY THE SURGEON OBSERVED A "JUMP IN THE AXIS" OF THE MICROSCOPE GUIDANCE FOR MARKING. THE IOLS WERE PLACED ACCORDING TO THE MANUAL MARKINGS AND THE POSTOPERATIVE OUTCOME WAS VERY GOOD WITH NO RESIDUAL ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT RECEIVED TO DATE. THIS IS ONE OF FOUR MEDICAL DEVICE REPORTS BEING FILED FOR THIS FACILITY.
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. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).