VERION DIGITAL MARKER M
Received Feb 12, 2016
Report 3010300699-2016-00004 · MDR key 5433889
Device
Generic name
Marker, Ocular
Manufacturer
Wavelight Gmbh (agps)Model number
X-SPMCatalog number
8065998243
Lot number
ASKU
Product problems
- Failure to Align
Patient
Not reported
- No Information
- No Information
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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).
Description of Event or Problem
A SURGEON REPORTED AN ALIGNMENT JUMP WITH THE SYSTEM. THIS RESULTED IN A MISALIGNMENT OF THE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Additional Manufacturer Narrative
DATA COLLECTION FOR INVESTIGATION REQUESTED AND NOT RECEIVED. NO ANOMALIES FOUND BY REVIEW OF DEVICE HISTORY RECORD. PRODUCT MET ALL SPECIFICATIONS WHEN RELEASED. NO TECHNICAL ROOT CAUSE COULD BE DETERMINED AS THE SYSTEM IS PERFORMING WITHIN SPECIFICATIONS. (B)(4).