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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 No Apparent Adverse Event (3189)
Patient Problems Corneal Ulcer (1796); Irritation (1941)
Event Date 03/24/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). (b)(6).
 
Event Description
On (b)(6) 2018, an eye care professional (ecp) in spain who reported a (patient) pt experienced torn lenses and eye irritation on (b)(6) 2018 while wearing 1-day acuvue trueye contact lenses (cls). The ecp reported the pt presented to the hospital, however, the diagnosis and treatment was unknown. On (b)(6) 2018 the ecp was contacted and provided the following information: ecp reported the pt was diagnosed with a ¿small¿ corneal ulcer on the right eye (od) and was prescribed eye drops (unspecified name, dosage, and duration). On (b)(6) 2018 the ecp was contacted and provided the following information: ecp reported that the ulcer had resolved and the pt¿s eye was fully recovered. The pt was instructed to discontinue cl wear for 2-3 weeks and the pt is currently wearing glasses. Multiple attempts were made for additional information. Additional information is not expected. The suspect cl is not available, as it was discarded. 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 5631820101 was produced under normal conditions. If additional information is received, will report 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 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 Key7469037
MDR Text Key106760985
Report Number9617710-2018-05030
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K073485
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 04/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/01/2022
Device Catalogue Number1D4
Device Lot Number5631820101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/27/2018 Patient Sequence Number: 1
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