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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); Burning Sensation (2146); Corneal Infiltrates (2231); Excessive Tear Production (2235)
Event Date 10/17/2017
Event Type  Injury  
Manufacturer Narrative
No testing methods performed. No results available since no evaluation performed. Unable to confirm complaint. Device not returned.
 
Event Description
On (b)(4) 2017 the affiliate in (b)(4) received a complaint from a patient (pt) reporting he/she experienced immediate burning sensation and sore left eye after removing a 1-day acuvue trueye brand contact lens. The pt presented to the eye care provider (ecp) on (b)(6) 2017 with complaints of left eye redness, photophobia, and tearing. The left eye was irritated with moderate hyperemia of the conjunctiva as well as hyperemia of the limbus. ¿on the cornea at 1 o'clock in the paracental zone infiltrate of an irregular triangular shape about 1. 5 mm in size with fuzzy contours, in shape resembles a trace from a possibly traumatic injury. The light staining with fluorescin sodium solution will be noted¿. On (b)(4) 2017 an email was received from the affiliate with additional medical information as follows: diagnosis: infiltrative keratitis of the left eye; antibiotic therapy was prescribed; the suspect lenses were discarded; the event date was (b)(6) 2017; the pt was examined again (date of the exam was not provided); after the antibiotic therapy, no eye pain, redness has decreased, signs of keratitis still persist; no problems removing the suspect lens; ¿the nature of the damage to the cornea (it was not a rounded infiltrate) indicates the presence of a possible micro damaging of the lens, which when blinking slightly shifted damaged the cornea¿. On (b)(4) 2017 an email was received from the affiliate with additional information: the treatment prescribed was tobramycin 0,3% 6 times per day; flocsal 0,3% 1 time over night; the patient continues to receive tobramycin 0, 3% 3 times per day + cornerogyl 2 times per day; the lens was ¿possibly chipped lens edges or a crack, the patient did not notice noting when putting the lens on the eye¿. On (b)(4) 2017 an additional email was received from the affiliate with additional information: the pt continues treatment only ¿keratoprotectors gel¿. No additional medical information has been received. No additional medical information is expected. 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 5824650110 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 Key7026237
MDR Text Key91917510
Report Number9617710-2017-05054
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeRS
PMA/PMN Number
K073485
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial
Report Date 10/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/01/2021
Device Catalogue Number1D4
Device Lot Number5824650110
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/06/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/13/2017 Patient Sequence Number: 1
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