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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 TRUEYE (NARA A) LENSES, SOFT CONTACT, DAILY WEAR

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JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 1-DAY ACUVUE TRUEYE (NARA A) LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number 1D4
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Irritation (1941); Pain (1994); Excessive Tear Production (2235); Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
On (b)(6) 2019, a patient (pt) from (b)(6) reported irritation and discomfort in the left eye (os) while wearing 1-day acuvue® trueye® (nara a) brand contact lenses (cl). The pt continued to wear the cls for a week and experienced an increase in pin-pricking pain, irritation, and tearing in the os after removal of the suspect cl. The pt sought medical attention on (b)(6) 2019 and was diagnosed with bacterial eye infection os. The pt was instructed to discontinue cl wear for 3 days and return for follow-up (fu). The pt was prescribed levofloxacin ophthalmic solution (unspecified dosage and frequency). On (b)(6) 2019, the pt returned for fu, and the eye care provider (ecp) found no issue with the os. No further treatment or fu was instructed. The pt currently has no problems with the os and has resumed cl wear in a different brand of cls. Event date is (b)(6) 2019. On (b)(6) 2019, additional information was received from the pt: the pt was prescribed levofloxacin ophthalmic solution 1. 5%, 5 times per day. On (b)(6) 2019, additional information was received from the treating ecp: the pt was seen on (b)(6) 2019 complaining of pain os. The pt was diagnosed with a corneal infection os, which the ecp considered infectious. The ecp prescribed antibiotic drops; culture was not conducted; focal site location: inferior part, outward from the center; size was not measured, but approximately 1 mm; pt was instructed to discontinue cl wear and return for fu. Pt returned for fu on (b)(6) 2019. Recovery not confirmed. The pt was allowed to return to cls wear on (b)(6) 2019 with no return of symptoms; no scarring noted. No additional information has been received. The suspect os cl is not available for return. 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 5836300106 was produced under normal conditions. If any further relevant information is received, a supplemental report will be filed.
 
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Brand Name1-DAY ACUVUE TRUEYE (NARA A)
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 Key8441639
MDR Text Key139540714
Report Number9617710-2019-00005
Device Sequence Number1
Product Code LPL
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
K073485
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation
Type of Report Initial
Report Date 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1D4
Device Lot Number5836300106
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/21/2019 Patient Sequence Number: 1
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