MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US 1-DAY ACUVUE MOIST BRAND MULTIFOCAL; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Conjunctivitis (1784); Irritation (1941); Red Eye(s) (2038)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2019 a patient (pt) called to report red eyes while wearing the 1-day acuvue® moist® brand multifocal.The pt had to stop wearing the lenses for a week.Pt called the eye care provider (ecp) but has not been able to get though and has not been seen in the office.On (b)(6) 2018 a call was placed to the pt and additional medical information was provided.Pt reported experiencing redness and irritation ou while wearing the suspect lenses.The ecp gave the pt trial lenses and the eyes ¿didn¿t seem to get any worse¿, then the ecp requested the pt come to the office for evaluation.The pt went to the ecp (date not provided) and advised the ¿eyes were filled with bacteria¿.Pt was prescribed tobramycin/dexamethasone ophthalmic suspension and systane complete eye drops ou for 10 days.The pt called the ecps office and advised the prescribed eye drops ¿needed to be used longer.¿ pt reported a fu appointment with the ecp is scheduled for (b)(6) 2019 and will call to provide additional medical information after the ecp visit.On (b)(6) 2019 a call was placed to the pts treating ecp¿s office and a representative provided additional information.The representative reported the ecp advised ¿not sure of the event was related to contacts.¿ pt went to the ecp on (b)(6) 2019 and diagnosed with ¿bacteria/allergic conjunctivitis.¿ pt was prescribed tobradex 1 drop tid ou for 10 days.The ecp considered the treatment ¿aggressive¿.Pts last contact lens exam was in 2017.Pt has a return appointment scheduled for tomorrow.Multiple attempts were made to contact the pts treating ecp for additional medical information, but nothing additional has been received.The date of the event was reported as 2019.The suspect lenses were requested for return for evaluation, but they have not been received.This report is for the pts od event.A separate report will be submitted for the pts os event.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 6509070103 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: 1-DAY ACUVUE MOIST BRAND MULTIFOCAL
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 8824039
• MDR Text Key: 152173797
• Report Number: 1057985-2019-00067
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2023
• Device Catalogue Number: 1MM
• Device Lot Number: 6509070103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention