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

Model Number X-SPM

Device Problems Self-Activation or Keying (1557); No Visual Prompts/Feedback (4021)

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

Event Date 12/10/2018

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 surgeon reported a flickering phenomenon during a procedure.The surgeon noted that he does not use the diagnostic tool anymore since the visible line designating the axis was flickering/changing by about 20 degrees.One second it would be there and the next it would be completely at a different axis.Surgeon feels that the system is possessed and is not sure what the correct axis is on some cases.All of the intraocular lens were off a little.They were all toric lenses (t2's) and it has not impacted outcomes much.The exact number of patients involved is unknown.Additional information has been requested.

Manufacturer Narrative

Product met specifications when released.Device history record (dhr) was reviewed.No root cause identified.A data collection to analyze the reported complaint was requested.However, based on the field service engineer's (fse's) feedback the hard drive of the system was already cleaned and a data collection is not possible anymore.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
• MDR Report Key: 8256312
• MDR Text Key: 133839129
• Report Number: 3010300699-2019-00001
• Device Sequence Number: 1
• Product Code: FTH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/17/2019
• Supplement Dates Manufacturer Received: 02/11/2019
• Supplement Dates FDA Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1