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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 Problems Unspecified Eye / Vision Problem (4471); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/20/2020
Event Type  Injury  
Manufacturer Narrative
The incident occurred due to incorrect handling of the device. The objective lens of the device had residue of balance salt solution (bss) which is used to rinse patient's eyes. It has been communicated to the hcp to be very cautious to not splash bss on or touch the objective lens before, during, and after any patient treatment.
 
Event Description
A healthcare professional (hcp) reported that during a smile procedure using the visumax laser system, black spots occurred on patient's both eyes. This made it difficult to separate the lenticule on the left eye. The hcp communicated that the patient had to come back at a later date to remove the lenticule remnants.
 
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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
9255574151
MDR Report Key11042178
MDR Text Key222634088
Report Number9615030-2020-00023
Device Sequence Number1
Product Code OTL
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P150040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
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 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 Received11/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/11/2018
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: 12/18/2020 Patient Sequence Number: 1
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