VISUMAX LASER KERATOME 000000-1345-518

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-03 for VISUMAX LASER KERATOME 000000-1345-518 manufactured by Carl Zeiss Meditec Ag (jena).

Event Text Entries

[91053157]
Patient Sequence No: 1, Text Type: N, H10


[91053158] The health care professional (hcp) reported a bad refractive outcome. The patient's post-operative ucva (uncorrected visual acuity) for od after visumax smile treatment was 20/50. The patient lost three lines of bscva (best spectacle-corrected visual acuity).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9615030-2017-00024
MDR Report Key7001480
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-11-03
Date of Report2017-10-25
Date of Event2017-05-12
Date Mfgr Received2017-10-25
Device Manufacturer Date2016-09-13
Date Added to Maude2017-11-03
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. WILLIAM GUSTAFSON
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, THUERINGIA 07745
Manufacturer CountryGM
Manufacturer Postal Code07745
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameVISUMAX LASER KERATOME
Generic NameFEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
Product CodeOTL
Date Received2017-11-03
Model NumberNA
Catalog Number000000-1345-518
Lot NumberNA
OperatorPHYSICIAN
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCARL ZEISS MEDITEC AG (JENA)
Manufacturer AddressCARL ZEISS PROMENADE 10 JENA, THUERINGIA 07745 GM 07745


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-11-03

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