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 Number: 1057985-2020-00005
• MDR Report Key: 9554711
• Report Source: CONSUMER,FOREIGN
• Date Received: 2020-01-06
• Date of Report: 2019-12-19
• Date of Event: 2019-12-18
• Date Mfgr Received: 2019-12-19
• Device Manufacturer Date: 2018-07-07
• Date Added to Maude: 2020-01-06
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: ROSE HARRELL
• Manufacturer Street: 7500 CENTURION PARKWAY
• Manufacturer City: JACKSONVILLE FL 32256
• Manufacturer Country: US
• Manufacturer Postal: 32256
• Manufacturer Phone: 9044433364
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ACUVUE? 2?
• Generic Name: LENSES, SOFT CONTACT, EXTENDED WEAR
• Product Code: LPM
• Date Received: 2020-01-06
• Model Number: NA
• Catalog Number: AV2
• Lot Number: B00QSMD
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: JOHNSON & JOHNSON VISION CARE, INC. ? US
• Manufacturer Address: 7500 CENTURION PARKWAY JACKSONVILLE FL US

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-01-06
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2020-01-06