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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 Keratitis (1944); Pain (1994); Discomfort (2330)
Event Date 07/15/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). (b)(6).
 
Event Description
On (b)(6) 2019 a patient (pt) in (b)(6) called to report discomfort and ¿soreness¿ in both eyes (ou) on (b)(6) 2019 while wearing the 1-day acuvue® trueye® brand contact lenses. Pt went to the eye care provider (ecp) on (b)(6) 2019 and was diagnosed with keratitis ou. Pt was prescribed antibiotic pills, anti-inflammatory pills, and an eye drop (medication names were not provided). The pt reported the eye drop was used 6 times a day. On (b)(6) 2019 a call was placed to the pt and additional information was provided. Pt was prescribed flumetholon ophthalmic suspension 0. 02%, quinovit eye drops and tearing eyes lubricant 6 times daily. Pt has not yet been cleared by the ecp to return to contact lens wear. The pt refused to provide the medical report. The suspect contact lenses were discarded. This report is for the right eye (od) event. A separate report will be filed for the left eye (os) event. 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 5821840103 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 Key8852637
MDR Text Key153082845
Report Number9617710-2019-00028
Device Sequence Number1
Product Code LPL
Combination Product (y/n)Y
Reporter Country CodeKN
PMA/PMN Number
K073485
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 07/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/01/2021
Device Catalogue Number1D4
Device Lot Number5821840103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/03/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/01/2019 Patient Sequence Number: 1
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