ORA SYSTEM 2000 8065998327

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-08-08 for ORA SYSTEM 2000 8065998327 manufactured by Alcon Research, Llc - Irvine Technology Center.

MAUDE Entry Details

Report Number2028159-2019-01455
MDR Report Key8873818
Report SourceOTHER
Date Received2019-08-08
Date of Report2019-08-19
Date Mfgr Received2019-08-14
Date Added to Maude2019-08-08
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 ContactMS. CINDY MILAM
Manufacturer Street6201 SOUTH FREEWAY MAIL STOP AB2-6
Manufacturer CityFORT WORTH TX 76134
Manufacturer CountryUS
Manufacturer Postal76134
Manufacturer Phone8176152231
Manufacturer G1ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
Manufacturer Street15800 ALTON PARKWAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameORA SYSTEM 2000
Generic NameABERROMETER, OPHTHALMIC
Product CodeNCF
Date Received2019-08-08
Model NumberNA
Catalog Number8065998327
Lot NumberASKU
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
Manufacturer Address15800 ALTON PARKWAY IRVINE CA 92618 US 92618


Patients

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

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