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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 Irritation (1941); Uveitis (2122); Blurred Vision (2137)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Initial reporter¿s phone number: (b)(6).
 
Event Description
On (b)(6) 2018 an email was received from a patient (pt) in (b)(6) reporting excessive movement, uneven color print and experienced irritation after insertion of the 1-day acuvue® define¿ with lacreon® brand contact lenses. The pt is an experienced wearer. The pt reported the event date as (b)(6) 2018. On (b)6) 2018 the pt reported the eye care provider (ecp) has not diagnosed the pt with uveitis, but the pt feels the ¿symptoms are similar¿ to a previous event. On (b)(6) 2018 the pt went to the emergency room visit (b)(6) 2018. Pt reported a diagnosis of uveitis in the od. The pt was prescribed steroid eye drops every hour for three hours, then reduce to once every two hours. The pt has a follow-up appointment with the ecp on (b)(6) 2018. The pt will send the medical documents. On (b)(6) 2018 an email was received from the pt with pharmacy receipt, prescription, and follow-up appointment letter. Pt reported the symptoms worsened on (b)(6) 2018 and the pt went to the hospital. Prescription dated (b)(6) 2018 for pred forte re qid for 1 month; cyclopentolate 1% re tds for 1 month; maxidex re nocte for 2 op. A follow-up appointment letter for (b)(6) 2018 with ecp @ 1:00pm. On (b)(6) 2018 an email was received from the pt who reported he/she contacted the treating ecp, but the ecp has not responded. On (b)(6) 2018 an email was received from the patient (pt) who provided a hospital medical record dated (b)(6) 2018: pt was referred to the hospital due to possible uveitis ou; pt was diagnosed with recurrence of right anterior/immediate uveitis; no medications were prescribed; pt complained of 1 week of floaters and blurred vision and a few weeks of discomfort; exam noted ac +1 cells and viritis +2 cells; plan included g pf q 1 hour for 3 days, g cyclo tds, return to clinic next week; ¿va measured 6/8. 6 od¿. On (b)(6) 2018 a call was placed to the patient (pt) and additional information was provided: pt missed doctor¿s appointments due to (b)(6) holidays, but plans to make another visit soon. Pt reported that the symptoms are subsiding. On (b)(6) 2018 additional information was received from the pt: pt reported that the lenses were returned for evaluation. Pt reported that her eye condition has been getting better with ¿irritations settling down¿. Pt reported the uveitis condition has ¿settled down¿ and pt doesn¿t plan to further visit her doctor on that matter. 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 3425230458 was produced under normal conditions. No additional medical information has been received. No additional information is expected. 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 Key7422901
MDR Text Key105240992
Report Number9617710-2018-05029
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
N18033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation
Type of Report Initial
Report Date 03/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/01/2020
Device Catalogue Number1DL
Device Lot Number3425230458
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/11/2018 Patient Sequence Number: 1
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