Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) VISUMAX; FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CARL ZEISS MEDITEC AG (JENA) VISUMAX; FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION Back to Search Results
Model Number N/A
Device Problem Calibration Problem (2890)
Patient Problem Insufficient Information (4580)
Event Date 10/31/2020
Event Type  malfunction  
Event Description
A health care professional reported that the visumax was incorrectly calibrated.The visumax was used on more than ten patients between (b)(6) 2020.Impact on the patients due to use of the visumax is not known.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VISUMAX
Type of Device
FEMTOSECOND 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 Key10901681
MDR Text Key241804568
Report Number9615030-2020-00018
Device Sequence Number1
Product Code OTL
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
P150040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Remedial Action Repair
Type of Report Initial
Report Date 10/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number000000-2174-830
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/19/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-