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U.S. Department of Health and Human Services

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

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CARL ZEISS MEDITEC AG (JENA) VISUMAX LASER KERATOME FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dry Eye(s) (1814); Vitreous Floaters (1866); Halo (2227); Anxiety (2328); Discomfort (2330); Eye Pain (4467)
Event Date 10/14/2020
Event Type  Injury  
Manufacturer Narrative
The manufacturer evaluated the available information and could not find a complaint, which would match with this event. No further data, (e. G. Any contact data of patient, health care professional location, or user facility) could be obtained. Nor any other device related data is available. The patient did not allege a device problem. The user manual for visumax identifies some of the side effects described by the patients as known contraindication and side effects that can be associated with the visumax laser procedure. The user manual also advises the health care professional to perform a clinical evaluation to identify any additional side effects from the relevant technical literature and medical associations. "side-effects and complications are not limited to this list. Please consult medical literature and associations for additional side effects".
 
Event Description
Carl zeiss meditec, inc. Received from the fda voluntary event report mw5096471, which was submitted by a patient. The patient reported experiencing side effects post lasik surgery in 2017. The side effects described by the patient are dry eye, floaters, halos, starburst, glare and poor night vision in both eyes. The patient further reported that these symptoms have caused persistent anxiety, pain and discomfort, adversely affecting everyday function, ability to work, quality of life mental health and general well being. The devices listed for treatment were the visumax femtosecond laser (manufactured by carl zeiss meditec) and the nidek ec-500 excimer laser.
 
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Brand NameVISUMAX LASER KERATOME
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
vernon brown
5160 hacienda drive
dublin, CA 94568
9255574689
MDR Report Key10825585
MDR Text Key215944599
Report Number9615030-2020-00014
Device Sequence Number1
Product Code OTL
Combination Product (y/n)N
PMA/PMN Number
P150040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 10/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2020
Was Device Evaluated by Manufacturer? No
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: 11/11/2020 Patient Sequence Number: 1
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