VERION DIGITAL MARKER M
Received Mar 2, 2017 · Event occurred Feb 2, 2017
Report 3010300699-2017-00003 · MDR key 6374890
Device
Generic name
Marker, Ocular
Manufacturer
Wavelight Gmbh (agps)Model number
X-SPMCatalog number
8065998244
Lot number
ASKU
Product problems
- Product Quality Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
NO TECHNICAL ROOT CAUSE COULD BE DETERMINED BASED ON THE INFORMATION THAT WAS PROVIDED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Additional Manufacturer Narrative
ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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 A VARIATION OF ALMOST 45 DEGREES BETWEEN TWO RECOGNITIONS FOR IMPLANTABLE CONTACT LENS (ICL) PRIOR TO IMAGE GUIDED CATARACT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.