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

Model Number X-SPM

Device Problems Device Operates Differently Than Expected (2913); Material Twisted/Bent (2981); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 12/21/2015

Event Type  Injury  

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 device history records (dhr) for the device was reviewed.The associated device was released based on company acceptance criteria.No anomalies found by review of device history record.Product met all specifications when released.The manufacturer internal reference number is: (b)(4).

Event Description

A doctor reported a toric intraocular lens was implanted wrongly about 22 while using digital marker device.Lens was twisted 22.5 clockwise.The preset of the sitting position as not been completely temporal (22.5) 79 was planned and ended up with 57.Revision was performed and 86 as the outcome.Upon follow up, there was not a wrong sitting position applied by the user.

Manufacturer Narrative

No anomalies found by review of device history record, product met all specifications when released.Product was not returned for investigation.Data was provided, however, the related surgery could not be identified in the data.The reported issue might not have been performed with the device reported.A wrong implanted iol can have several causes.If the doctor selects the wrong doctor position, the device will not be able to register the correct angle.Poor illumination can also be a reason for not properly registering.In both cases, the surgeon must confirm that the registration of the image has been established successfully to proceed with the workflow.All described possibilities are a result of improper handling of the device.If more data becomes available for further investigation, information will be updated accordingly.(b)(4).

Event Description

A necessary correction was identified regarding incident description narrative previously provided.The statement "upon follow up, there was not a wrong sitting position applied by the user" was a comment from a company representative and not a verified fact.

• 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: eddie darton, md, jd ; am wolfsmantel 5; erlangen 91058 ; GM 91058 ; 8175686660
• MDR Report Key: 5568886
• MDR Text Key: 42411991
• Report Number: 3010300699-2016-00016
• 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
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• 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: 8065998244
• Device Lot Number: ASKU
• Other Device ID Number: 00380659982446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2015
• 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