IOLMASTER 700 N/A 000000-2181-545

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 2019-05-08 for IOLMASTER 700 N/A 000000-2181-545 manufactured by Carl Zeiss Meditec Ag (jena).

Event Text Entries

[144452119] .
Patient Sequence No: 1, Text Type: N, H10


[144452120] A health care professional (hcp) reported that the biometry measurement and lens power calculation data of patient b was acquired in the profile of patient a using the iolmaster 700. The erroneous data was then used to implant a lens on patient a causing an incorrect surgical result. The hcp reported that a lens exchange had been performed to correct the patient's vision.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9615030-2019-00007
MDR Report Key8591945
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-05-08
Date of Report2019-04-08
Date of Event2019-03-06
Date Mfgr Received2019-04-08
Device Manufacturer Date2017-04-12
Date Added to Maude2019-05-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 NameIOLMASTER 700
Generic NameBIOMICROSCOPE, SLIT-LAMP, AC-POWERED
Product CodeHJO
Date Received2019-05-08
Model NumberN/A
Catalog Number000000-2181-545
Lot NumberN/A
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCARL ZEISS MEDITEC AG (JENA)
Manufacturer AddressCARL ZEISS PROMENADE 10 JENA, 7745 GM 7745


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-05-08

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