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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
Catalog Number 000000-1345-518
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dry Eye(s) (1814); Vitreous Floaters (1866); Headache (1880); Nausea (1970); Blurred Vision (2137); Visual Impairment (2138)
Event Date 07/04/2018
Event Type  Injury  
Manufacturer Narrative
The manufacturer reviewed the on-site service documentation which confirmed that the device was working within specification. The investigation has not identified any abnormality or product deficiency related to the incident. The manufacturer reviewed the document labelling for visumax laser keratome. The user manual (ifu 000000-1345-518-doks-sm-kr-211114, p. 6-9) describes ectasia as a contraindication and side effect that can be associated with the visumax laser procedure. Moreover the user manual describes headache, dry eye, visual disturbance as side effects that can be associated with the visumax laser procedure. The user manual also advises the healthcare professional to perform a clinical evaluation to identify any additional side effects from the relevant technical literature and medical associations.
 
Event Description
On 11/29/2018, carl zeiss meditec (czm) received a voluntary report (mw5081613) from the fda submitted by a patient who underwent a relex smile surgery on (b)(6) 2018 with the visumax device and collagen-cross linking (cxl). Cxl is a treatment that is provided by a third party company and it is not in the responsibility of czm. Per the report, the patient's eye sight was not corrected to 1. 0 after the surgery - the patient's vision on the left eye was reported to be 0. 5 while the right eye was reported to be 0. 6. The patient reported seeking other doctors' opinions. They communicated to the patient that this is an irregular astigmatism which cannot be corrected by glasses. The patient reported experiencing numerous side effects such as headaches, nausea, double vision, blurry vision, ghosting, glare, starburst, shadows, dry eye, eye burning, eye pain, floaters and ectasia. Treatment videos and patient information were requested from the eye clinic in (b)(6), but due to local regulations, it has not been provided. The patient's pre-operative conditions are currently unknown and stable post-operative information were not provided for each eye.
 
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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 07745
GM 07745
Manufacturer (Section G)
CARL ZEISS MEDITEC AG (JENA)
carl zeiss promenade 10
jena, thueringia 07745
GM 07745
Manufacturer Contact
vernon brown
5160 hacienda drive
dublin, CA 94568
9255574616
MDR Report Key8192604
MDR Text Key131302578
Report Number9615030-2018-00014
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 consumer,foreign,other
Reporter Occupation
Type of Report Initial
Report Date 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number000000-1345-518
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/03/2016
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: 12/21/2018 Patient Sequence Number: 1
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