VERION DIGITAL MARKER M
Received Feb 24, 2020 · Event occurred Dec 3, 2019
Report 3010300699-2020-00001 · MDR key 9748363
Device
Generic name
Marker, Ocular
Manufacturer
Wavelight Gmbh (agps)Model number
X-SPMCatalog number
8065998244
Lot number
ASKU
Product problems
- Malposition of Device
Patient
32 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem
A HEALTHCARE PROFESSIONAL REPORTED HAVING TO ROTATE TORIC INTRAOCULAR LENS (IOL) TO THE CORRECT AXIS PER SYSTEM. THE HEALTHCARE PROFESSIONAL CHECKED WITH THE SLIT LAMP POST OPERATIVELY AND THE IOL WAS NINE DEGREES IN THE OPPOSITE DIRECTION. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM AND TRIED TO REREGISTER WITH THE SYSTEM WHICH INDICATED IN FACT THE LENS WAS IN THE CORRECT POSITION WHEN IT WAS NOT. THE IOL WAS STILL SITTING IN THE OPPOSITE DIRECTION WHICH IS WHAT THE GUIDE HAD ORIGINALLY USED. IOL WAS RE-ROTATED POST OPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED. THE SURGEON DID A BIT OF PROBLEM SOLVING WHICH PARTIALLY RESOLVED THE ISSUE. THE SURGEON HAD TO GUESSTIMATE THE AXIS OF THE TORIC IOL. POST-OPERATIVELY, THE AXIS WAS SITTING ABOUT FOUR-FIVE DEGREES INSTEAD OF NINE DEGREES. THIS WAS MUCH BETTER THAN BEING NINE DEGREES OFF IN THE OTHER DIRECTION.
Additional Manufacturer Narrative
THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
Description of Event or Problem
NEW INFORMATION WAS RECEIVED. THE ORIENTATION WAS ESSENTIALLY CORRECTED AFTER THE ORIGINAL ALIGNMENT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION PROVIDED IN H.3., H.6., AND H.10. THE ROOT CAUSE IS UNABLE TO BE VERIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).