VISUMAX LASER KERATOME

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-07-12 for VISUMAX LASER KERATOME manufactured by Carl Zeiss Meditec Ag (jena).

MAUDE Entry Details

Report Number9615030-2019-00010
MDR Report Key8786762
Report SourceCONSUMER
Date Received2019-07-12
Date of Report2019-06-12
Date of Event2018-07-03
Date Mfgr Received2019-06-12
Date Added to Maude2019-07-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. VERNON BROWN
Manufacturer Street5160 HACIENDA DRIVE
Manufacturer CityDUBLIN CA 94568
Manufacturer CountryUS
Manufacturer Postal94568
Manufacturer Phone9255574689
Manufacturer G1CARL ZEISS MEDITEC AG (JENA)
Manufacturer StreetCARL ZEISS PROMENADE 10
Manufacturer CityJENA, 7745
Manufacturer CountryGM
Manufacturer Postal Code7745
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameVISUMAX LASER KERATOME
Generic NameFEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
Product CodeOTL
Date Received2019-07-12
Model NumberNA
Catalog NumberNA
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCARL ZEISS MEDITEC AG (JENA)
Manufacturer AddressCARL ZEISS PROMENADE 10 JENA, 7745 GM 7745


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-07-12

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