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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 Problem Eye Injury (1845)
Event Date 02/08/2017
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-ga-sm-fr-290811, page 7 and 8) describes ectasia as a contraindication and side effect that can be associated with the visumax laser procedure. The user manual also advises the hcp to perform a clinical evaluation to identify any additional side effects from the relevant technical literature and medical associations.
 
Event Description
The health care professional (hcp) reported a case of suspected corneal ectasia for a patient post visumax laser keratome treatment. The hcp also reported that the separation of the lenticle was difficult during treatment. After one year and three months post treatment the patient's uncorrected visual acuity is 4/10 and corrected visual acuity is 7/10, -1. 00(-1. 50) 40°. All pertinent information available to carl zeiss meditec has been submitted.
 
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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
william gustafson
5160 hacienda drive
dublin, CA 94568
9255574689
MDR Report Key6397754
MDR Text Key69734556
Report Number9615030-2017-00004
Device Sequence Number1
Product Code OTL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P150040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Remedial Action Inspection
Type of Report Initial
Report Date 03/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2017
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/11/2012
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: 03/11/2017 Patient Sequence Number: 1
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