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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 1-DAY ACUVUE DEFINE WITH LACREON LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
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.
 
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Brand Name1-DAY ACUVUE DEFINE WITH LACREON
Type of DeviceLENSES, 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 Key7175100
MDR Text Key96813459
Report Number9617710-2018-05002
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N18033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
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 Received01/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/01/2022
Device Catalogue Number1DL
Device Lot Number2338340103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/12/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/09/2018 Patient Sequence Number: 1
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