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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 Failure to Align (2522)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/09/2021
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 manufacturer internal reference number is: (b)(4).
 
Event Description
A physician reported a deviation in axis was displayed on digital marker microscope (dmm) during surgery. The doctor had doubts about inserting the intraocular lens (iol) at the axis displayed on dmm. Axis deviation of about 20 degrees was found post surgery when iol position was checked. An operation to adjust the axis was later performed. The surgery was completed. The doctor said there might have been a difference between the position of a microscope during setup and its actual position.
 
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Brand NameVERION DIGITAL MARKER M
Type of DeviceMARKER, 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
jonathan schlech
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514979
MDR Report Key12297344
MDR Text Key265764843
Report Number3010300699-2021-00003
Device Sequence Number1
Product Code FTH
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberX-SPM
Device Catalogue Number8065998244
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/09/2021 Patient Sequence Number: 1
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