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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 Problems Contamination (1120); Optical Obstruction (3002); Device Handling Problem (3265)
Patient Problem Unspecified Eye / Vision Problem (4471)
Event Date 01/02/2021
Event Type  Injury  
Manufacturer Narrative
The incident occurred due to incorrect handling of the device. Based on the evaluation of the treatment video, the manufacturer was able to identify dirt particles on the contact glass of the treatment pack. This dirt particle was identified as a fingerprint. The hcp moved the treatment pack for quite long time (approx. 15 seconds) lateral on the eye. This increases the risk to pump meibom secret (oily part of the tears) to the surface of the cornea. This secret blocks the laserbeam of the visumax. Therefore, the incision was incomplete. Nevertheless, the lenticule was attempted to be removed by the hcp. This decision is based on a user error. According to the instructions for use, the procedure should be aborted if incomplete cuts are created.
 
Event Description
A health care professional (hcp) reported that there was an unidentified material on the contact glass of the treatment pack of visumax. The hcp decided to proceed with the surgery. The hcp communicated that dissection was extremely difficult, making proper delineation of the lenticlue almost impossible. As a result a significant volume of the lenticule was torn off and left in the patient's cornea. The current status of the patient is unknown. The hcp will follow up with patient and determine if further treatment is needed.
 
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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 7745
GM 7745
Manufacturer (Section G)
CARL ZEISS MEDITEC AG (JENA)
carl zeiss promenade 10
jena, thueringia 7745
GM 7745
Manufacturer Contact
viet nguyen
5160 hacienda drive
dublin, CA 94568
9255574689
MDR Report Key11402203
MDR Text Key234406521
Report Number9615030-2021-00005
Device Sequence Number1
Product Code OTL
Combination Product (y/n)N
Reporter Country CodeKS
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 02/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number000000-1345-518
Device Lot NumberS195179
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 Received02/02/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/13/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/02/2021 Patient Sequence Number: 1
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