MAUDE Adverse Event Report: WAVELIGHT GMBH (AGPS) VERION DIGITAL MARKER M; MARKER, OCULAR

Model Number X-SPM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

A service visit was performed.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 and not received.(b)(4).

Event Description

An ophthalmic surgeon reported that the implantation axis was noticed to be not correct in a pool of patients after cataract surgeries with intraocular lens (iol) implant.This report is for a patient who had a 30ꠇap in the implantation axis.It is unknown if any intervention was performed on this patient.Additional information has been requested but not received.This is one of three reports being filed for the same facility and event.

Manufacturer Narrative

Evaluation summary: sample was not returned.No microscope data for the related patient (preop/postop/) received.No technical root cause could be determined based on the information that was provided.Contributing factors for reported event could be a selecting incorrect doctor position during planning phase, a changing of doctor/microscope position after confirmation of the registration or guidelines of an appropriate surgery image where not followed (e.G too low microscope illumination, zoom level of the microscope too high or too low or bad centration of the eye during the surgery).Most likely the root cause is use error.(b)(4).

• Brand Name: VERION DIGITAL MARKER M
• Type of Device: MARKER, OCULAR
• Manufacturer (Section D): WAVELIGHT GMBH (AGPS); rheinstrasse 8; telow berlin 14513 ; GM 14513
• Manufacturer (Section G): WAVELIGHT GMBH (AGPS); rheinstrasse 8; telow berlin 14513 ; GM 14513
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5486199
• MDR Text Key: 39884059
• Report Number: 3010300699-2016-00009
• Device Sequence Number: 1
• Product Code: FTH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X-SPM
• Device Catalogue Number: 8065998242
• Other Device ID Number: 2.6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention