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

Catalog Number 1DL

Device Problem No Apparent Adverse Event (3189)

Patient Problems Conjunctivitis (1784); Red Eye(s) (2038); Discomfort (2330)

Event Date 01/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporters phone number: (b)(6).

Event Description

On (b)(6) 2017 a patient (pt) called our affiliate in (b)(6) to report that while wearing the 1-day acuvue define lenses, he/she experienced discomfort and redness on both eyes on (b)(6) 2017.The pt reported that he/she went to an eye care provider (ecp) and was diagnosed with conjunctivitis ou.The pt reported that he/she was prescribed levoxacin and sodium hyaluronate eye drops, both drops to be used every 1-2 hours.The pt reported that the ¿eyes were still red today, but better than yesterday.¿ on (b)(6) 2017 an additional call was placed to the pt and the additional information was obtained as follows: the pt reported that he/she had a follow-up visit with the ecp on (b)(6) 2017.The pt reported that the ecp advised that ¿the eye condition had greatly improved.¿ the pt reported that he/she ¿stopped using the levoxacin eye drops, but still using sodium hyaluronate eye drops three to four times a day.¿ the pt also reported that ¿it was not bacterial infection.¿ the pt reported that the suspect product has been discarded.No additional medical information has been received.The event is being reported as a worst case event for the pts od event.The pts os event will be filed as a separate report.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 3904690101 was produced under normal conditions.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

Manufacturer Narrative

It was noted in a file review on 09feb2017 that the expiration date for the lot # 3904690101 in the initial mdr submitted on 01feb2017.The expiration date is: 01-oct-2020.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: 1-DAY ACUVUE DEFINE WITH LACREON
• 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: 6294120
• MDR Text Key: 66279265
• Report Number: 1033553-2017-00025
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: 1DL
• Device Lot Number: 3904690101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2015
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention