VERION DIGITAL MARKER L
Received Mar 21, 2017 · Event occurred Feb 22, 2017
Report 3010300699-2017-00004 · MDR key 6420252
Device
Generic name
Marker, Ocular
Manufacturer
Wavelight Gmbh (agps)Model number
X-SPLCatalog number
8065998241
Lot number
ASKU
Product problems
- Malposition of Device
Patient
Not reported
- Corneal Touch
- Corneal Touch
Narrative
Additional Manufacturer Narrative
NO TECHNICAL ROOT CAUSE COULD BE DETERMINED. A POTENTIAL CONTRIBUTING FACTOR COULD BE RELATED TO AN INCORRECT SELECTION OF DOCTOR SEATING POSITION MAY RESULT IN A WRONG DISPLAYED AXIS SHOWN IN THE OVERLAY AND COULD LEAD TO THE REPORTED PROBLEM. (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. (B)(4).
Description of Event or Problem
A SURGEON REPORTED A CASE OF OBLIQUE ASTIGMATISM POST CATARACT PROCEDURE. THE REPORTER INDICATED THE IMAGE GUIDED SYSTEM RECOMMENDED AXIAL PLACEMENT WAS OFF ALIGNMENT AND DID NOT CORRECT THE CYLINDER POWER. REPORTER INDICATED THE INTRAOCULAR LENS (IOL) WAS ROTATED THREE DAYS LATER, AND PATIENT IS DOING WELL.
Remedial action
- Other