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

Model Number X-SPM

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/04/2017

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.(b)(4).

Event Description

A doctor reported there is a jump in axis by about 30 degrees.Upon follow up, surgery went well and was completed.No patient harm was reported.The physician decided the correct setting for the axis.There are two related reports.This report addresses the (b)(6) 2017 event and another manufacturer report will be filed for the occasionally occurrences.

Manufacturer Narrative

No anomalies found by review of device history record.Product met all specifications when released.Use error which was caused by a misunderstanding between the local clinical applications specialist (cas) and the surgeon which could be clarified with a re-training.Additionally, the data analysis showed inappropriate reference and surgery image used for registration on the system which the cas will re-train the site on how to follow the instructions correctly.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Upon additional follow up, the nurse provided that the left eye was affected.Nurse informed that the last setting of the axis was 170°.It was not reproducible for nurse whether this setting was made manually or whether it was a default setting.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Review of surgery data shows that flipping axis is due to the change in step from incision step directly to toric implantation step in the digital marker m.As the clinic moved from incision step with the steep axis to the toric step the implantation axis was shown in as the overlay which was set to 172 degrees.The implantation axis is not jumping as mentioned in the complaint.It is just the change in the steps which results in displaying different axis.The device does meet its specifications.The manufacturer internal reference number is: (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: 6750584
• MDR Text Key: 81475086
• Report Number: 3010300699-2017-00019
• Device Sequence Number: 1
• Product Code: FTH
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup,Followup,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8065998244
• Device Lot Number: ASKU
• Other Device ID Number: 2.6.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2017
• Initial Date FDA Received: 07/28/2017
• Supplement Dates Manufacturer Received: 09/06/2017; 08/08/2017; 11/09/2017; 11/24/2017
• Supplement Dates FDA Received: 09/15/2017; 11/09/2017; 11/17/2017; 12/01/2017
• 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