ACUVUE? 2? DEFINE? A2D

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-11-25 for ACUVUE? 2? DEFINE? A2D manufactured by Johnson & Johnson Vision Care, Inc. ? Ireland.

MAUDE Entry Details

Report Number9617710-2019-00048
MDR Report Key9372129
Report SourceCONSUMER,FOREIGN
Date Received2019-11-25
Date of Report2019-11-05
Date of Event2019-11-04
Date Mfgr Received2019-11-05
Device Manufacturer Date2015-05-20
Date Added to Maude2019-11-25
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? 2? DEFINE?
Generic NameLENSES, SOFT CONTACT, EXTENDED WEAR
Product CodeLPM
Date Received2019-11-25
Model NumberNA
Catalog NumberA2D
Lot Number3618240356
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerJOHNSON & JOHNSON VISION CARE, INC. ? IRELAND
Manufacturer AddressONE TECHNOLOGICAL PARK PLASSEY LIMERICK EI


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2019-11-25

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