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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) VISUMAX FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION

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CARL ZEISS MEDITEC AG (JENA) VISUMAX FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION Back to Search Results
Model Number N/A
Device Problem Misassembly During Maintenance/Repair (4054)
Patient Problem Insufficient Information (4580)
Event Date 11/07/2020
Event Type  malfunction  
Event Description
A healthcare professional reported that the visumax had an incorrect laser pattern. The visumax was used on two patients. Impact on the patients due to use of the visumax is not known.
 
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Brand NameVISUMAX
Type of DeviceFEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
Manufacturer (Section D)
CARL ZEISS MEDITEC AG (JENA)
carl zeiss promenade 10
jena, thueringia 07745
GM 07745
Manufacturer (Section G)
CARL ZEISS MEDITEC AG (JENA)
carl zeiss promenade 10
jena, thueringia 07745
GM 07745
Manufacturer Contact
viet nguyen
5160 hacienda drive
dublin, CA 94568
9255574151
MDR Report Key10962499
MDR Text Key231798601
Report Number9615030-2020-00019
Device Sequence Number1
Product Code OTL
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
P150040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 11/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number000000-1345-518
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/04/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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