ACUVUE? OASYS? PH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2019-11-19 for ACUVUE? OASYS? PH manufactured by Johnson & Johnson Vision Care, Inc. ? Us.

MAUDE Entry Details

Report Number1057985-2019-00129
MDR Report Key9342831
Report SourceFOREIGN,OTHER
Date Received2019-11-19
Date of Report2019-10-28
Date Mfgr Received2019-10-28
Date Added to Maude2019-11-19
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 ContactROSE HARRELL
Manufacturer Street7500 CENTURION PARKWAY
Manufacturer CityJACKSONVILLE FL 32256
Manufacturer CountryUS
Manufacturer Postal32256
Manufacturer Phone9044433364
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameACUVUE? OASYS?
Generic NameLENSES, SOFT CONTACT, EXTENDED WEAR
Product CodeLPM
Date Received2019-11-19
Model NumberNA
Catalog NumberPH
Lot NumberB00QG1S
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerJOHNSON & JOHNSON VISION CARE, INC. ? US
Manufacturer Address7500 CENTURION PARKWAY JACKSONVILLE FL US


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2019-11-19

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