ACUVUE? 2? AV2

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 2020-01-06 for ACUVUE? 2? AV2 manufactured by Johnson & Johnson Vision Care, Inc. ? Us.

Event Text Entries

[187461366] (b)(4). Initial reporter? S phone number: (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[187461367] On 19dec2019, a patient (pt) in brazil reported a diagnosis of chemical conjunctivitis ou while wearing acuvue? 2? Brand contact lenses (cl). The pt inserted two lenses from two new blister packs and wore the lenses for 6 hours without symptoms. After 6 hours of wear the pt experienced redness, tearing, and pain ou on (b)(6) 2019. The pt? S ou were red, sore, irritated, photophobic, and swollen upon removal of cls. The pt visited an eye care provider (ecp) on (b)(6) 2019 and was diagnosed with chemical conjunctivitis. The pt was prescribed vigamox, 1 drop ou, every 4 hours for 5 days. The pt was prescribed iv pain medication (cetaprofeno / dipirona) while the pt was in the hospital. The pt was not advised to return for a follow-up visit. The pt reported daily wear with monthly replacement of cls. The pt? S ou are much better today, but are currently red, sore, photophobic, and swollen. The pt will attempt to obtain a copy of the medical records. Multiple attempts were made to contact the treating ecp for additional information, but no further information was received. No additional medical information has been received. The suspect os contact lens was requested for return for evaluation, but it has not been received. A lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing. All parameters tested were within specification. All sterilization requirements were successfully completed. Lot b00qsmd was produced under normal conditions. This report is for the pt's os event. The report for the pt's od event will be submitted in a separate report. If any further relevant information is received, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1057985-2020-00005
MDR Report Key9554711
Report SourceCONSUMER,FOREIGN
Date Received2020-01-06
Date of Report2019-12-19
Date of Event2019-12-18
Date Mfgr Received2019-12-19
Device Manufacturer Date2018-07-07
Date Added to Maude2020-01-06
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 Sequence Number: 1

Brand NameACUVUE? 2?
Generic NameLENSES, SOFT CONTACT, EXTENDED WEAR
Product CodeLPM
Date Received2020-01-06
Model NumberNA
Catalog NumberAV2
Lot NumberB00QSMD
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerJOHNSON & JOHNSON VISION CARE, INC. ? US
Manufacturer Address7500 CENTURION PARKWAY JACKSONVILLE FL US

Device Sequence Number: 101

Product Code---
Date Received2020-01-06
Device Sequence No101
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2020-01-06

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