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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 Irritation (1941); Keratitis (1944); Pain (1994); Red Eye(s) (2038)
Event Type  Injury  
Manufacturer Narrative
(b)(4). (b)(6).
 
Event Description
On (b)(6) 2018, a patient (pt) from (b)(6) wearing 1-day acuvue trueye contact lenses (cls) reported that in (b)(6) 2018 the pt experienced irritation, redness, and pain after removal of the cl and visited an eye care professional (ecp). The pt was diagnosed with keratitis in the left eye (os). The pt was prescribed antibacterial eye drops (unspecified name, dosage, duration) and was instructed to discontinue cl wear for two weeks. The pt¿s os is currently recovered. The suspect product was discarded. On (b)(6) 2018, the pt was contacted and reported that the eye drops that were prescribed were gatiflo eye drops 0. 3% (gatifloxacin hydrate), to be applied every 2-3 hours for the first 3 days until the follow-up visit and then tid. The pt revisited the clinic after a week from the follow-up visit and was diagnosed with recovery and was instructed to discontinue the gatiflo eye drops. Additional information is not available as the patient refused consent to contact the treating ecp. 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 5829210105 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 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 Key7527240
MDR Text Key108728167
Report Number9617710-2018-05034
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeJA
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 04/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2018
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 Number5829210105
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/18/2018 Patient Sequence Number: 1
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