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 Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2017

Event Type  malfunction  

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).

Event Description

A surgeon reported; after implantation of the intraocular lens during image guided cataract surgery it was found that the system marker shows the implantation axis at two degrees.The surgeon reviewed the treatment plan and found the axis should be at eleven.After reboot of the system the marker displayed the correct axis which aligned with the data print out.No patient harm reported.

Manufacturer Narrative

No anomalies found by review of device history record.Product met all specifications when released.Based on the provided data collection of this case a user error can be confirmed.The initial surgical plan shows the reported 11° as implantation axis.However based on the provided data, on the planning screen the implantation axis was manually changed to 2°.Accordingly these 2° have been shown during surgery as implantation axis.The field service engineer was on site and retrained the customer relating to these issues.(b)(4).

• Brand Name: VERION DIGITAL MARKER M
• Type of Device: MARKER, OCULAR
• Manufacturer (Section D): WAVELIGHT GMBH (AGPS); rheinstrasse 8; teltow 14513 ; GM 14513
• Manufacturer (Section G): WAVELIGHT GMBH (AGPS); rheinstrasse 8; teltow 14513 ; GM 14513
• Manufacturer Contact: nadia bailey ; rheinstrasse 8; teltow D-145-13 ; GM D-14513 ; 8176152230
• MDR Report Key: 6802020
• MDR Text Key: 83128154
• Report Number: 3010300699-2017-00025
• Device Sequence Number: 1
• Product Code: FTH
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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
• Type of Report: Initial,Followup
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X-SPM
• Device Catalogue Number: 8065998242
• Device Lot Number: ASKU
• Other Device ID Number: 00380659982422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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