VERION DIGITAL MARKER M
Received Mar 2, 2017 · Event occurred Feb 6, 2017
Report 3010300699-2017-00002 · MDR key 6374889
Device
Generic name
Marker, Ocular
Manufacturer
Wavelight Gmbh (agps)Model number
X-SPMCatalog number
8065998244
Lot number
ASKU
Product problems
- Product Quality Problem
Patient
63 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SYSTEM DATA RECEIVED AND ANALYZED. THE ROOT CAUSE WAS IDENTIFIED AS USER ERROR. SYSTEM DATA PROVIDES EVIDENCE THAT THE SURGEON HAS SELECTED A DOCTOR POSITION OF -90 DEGREES INSTEAD OF +90 DEGREES. THE DEVICE IN THIS CASE IS NOT ABLE TO REGISTER THE DIAGNOSTIC IMAGE TO THE PATIENT'S IMAGE WHICH RESULTED IN A WRONG REGISTRATION ANGLE. THE SURGEON DID NOT FURTHER NOT REVIEW THE PROVIDED REGISTRATION ANGLE WHICH CONFIRMED WRONG ASTIGMATISM AXIS, AND RESULTED IN AN INCORRECT IMPLANTED INTRAOCULAR LENS (IOL. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED, A RESTART OF THE MACHINE RESOLVED THE ISSUE AND THERE WERE NO CONSEQUENCES TO PATIENTS.
Additional Manufacturer Narrative
THE USER RECOGNIZED THIS ISSUE WHEN CHECKING THE PROPOSED REGISTRATION ACCORDING TO USER INSTRUCTION. THERE WAS NO IMPACT TO THE PATIENT. THE ROOT CAUSE WAS A GENERAL LACK OF UNDERSTANDING THE DEVICE. (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 30-40 DEGREES DIFFERENCE BETWEEN TWO RECOGNITIONS FOR IMPLANTABLE CONTACT LENS PRIOR TO IMAGE GUIDED CATARACT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.