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U.S. Department of Health and Human Services

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

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WAVELIGHT GMBH (AGPS) VERION DIGITAL MARKER M; MARKER, OCULAR Back to Search Results
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).
 
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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 Key6750584
MDR Text Key81475086
Report Number3010300699-2017-00019
Device Sequence Number1
Product Code FTH
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 NumberX-SPM
Device Catalogue Number8065998244
Device Lot NumberASKU
Other Device ID Number2.6.0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/04/2017
Initial Date FDA Received07/28/2017
Supplement Dates Manufacturer Received09/06/2017
08/08/2017
11/09/2017
11/24/2017
Supplement Dates FDA Received09/15/2017
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 Number1
Patient Outcome(s) Other;
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