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

Catalog Number 1DL

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bacterial Infection (1735); Itching Sensation (1943); Red Eye(s) (2038); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

On (b)(6) 2017 a patient (pt) called our affiliate in (b)(4) to report itching and redness in both eyes while wearing the 1-day acuvue® define¿ with lacreon® brand contact lenses.The pt reported he/she is a new wearer of the lenses.The pt reported working in a hospital and the eyes were checked by a friend that is a doctor with a slit lamp.The pt reported the doctor also examined the tear and eye secretions and diagnosed ¿bacterial infection¿.The pt reported the doctor did not give the pt a report and the pt did not know what kind of ¿bacteria¿ was diagnosed.The pt was prescribed levofloxacin eye drops tid and reported the eyes were better after four days.The pt reported the right eye was more affected.The pt reported opening a new pair of contact lenses and noticed ¿floc¿ in the solution.Pt reported washing the lenses in opti-free lens care solution, then inserted the lenses.Pt reported the lenses felt comfortable at first, but after three to four hours the pt could feel the lenses in the eyes and both eye turned itchy and red again.The pt reported using the levofloxacin eye drops for a couple of times and the eyes were fine.Pt reported opening the third pair of lenses and noticed ¿floc¿ in the solution.No additional information was received.The date of event was reported as (b)(6) 2017.Additional information was requested from the affiliate.The suspect lenses were discarded.This report is for the pts right eye event.The event for the pts left eye will be filed in 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 2338340103 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.

• Brand Name: 1-DAY ACUVUE DEFINE WITH LACREON
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7175100
• MDR Text Key: 96813459
• Report Number: 9617710-2018-05002
• 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
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: 1DL
• Device Lot Number: 2338340103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2017
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention