ORA SYSTEM WITH VERIFEYE MESSAGING 8065998330

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-18 for ORA SYSTEM WITH VERIFEYE MESSAGING 8065998330 manufactured by Alcon Research, Llc - Irvine Technology Center.

MAUDE Entry Details

Report Number2028159-2019-02074
MDR Report Key9335041
Report SourceHEALTH PROFESSIONAL
Date Received2019-11-18
Date of Report2019-11-18
Date of Event2019-10-10
Date Mfgr Received2019-10-24
Device Manufacturer Date2017-06-20
Date Added to Maude2019-11-18
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 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 WITH VERIFEYE MESSAGING
Generic NameABERROMETER, OPHTHALMIC
Product CodeNCF
Date Received2019-11-18
Model NumberNA
Catalog Number8065998330
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2019-11-18

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