VERION DIGITAL MARKER M
Received Oct 10, 2016 · Event occurred Aug 15, 2016
Report 3010300699-2016-00046 · MDR key 6013949
Device
Generic name
Marker, Ocular
Manufacturer
Wavelight Gmbh (agps)Model number
X-SPMCatalog number
8065998244
Lot number
ASKU
Product problems
- Positioning Problem
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION HAS BEEN REQUESTED. NO ANOMALIES FOUND BY REVIEW OF DEVICE HISTORY RECORD, PRODUCT MET ALL SPECIFICATIONS WHEN RELEASED. REPORTED EVENT RESULTED FROM THE FAILURE OF THE CUSTOMER TO FOLLOW PUBLISHED INSTRUCTIONS FOR USE. (B)(4).
Description of Event or Problem
AN OPHTHALMOLOGIST REPORTED THAT ONE DAY FOLLOWING TORIC INTRAOCULAR LENS (IOL) IMPLANT SURGERY IN THE LEFT EYE, THE PATIENT PRESENTED WITH AN UNPLANNED LENS ROTATION. THE TARGET AXIS OF THE IOL WAS AT 170 DEGREES, BUT INSTEAD, IT WAS AT 10 DEGREES. THE SURGEON IS CONCERNED THAT THE POSITIONING SYSTEM PROVIDED INCORRECT AXIS PLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Additional Manufacturer Narrative
NO ANOMALIES FOUND BY REVIEW OF DEVICE HISTORY RECORD, PRODUCT MET ALL SPECIFICATIONS WHEN RELEASED. A WRONG REGISTRATION PROPOSAL WAS CONFIRMED BY THE USER. REPORTED EVENT RESULTED FROM THE FAILURE OF THE CUSTOMER TO FOLLOW PUBLISHED INSTRUCTIONS FOR USE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).