MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 1-DAY ACUVUE TRUEYE (NARA A); LENSES, SOFT CONTACT, DAILY WEAR

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.

• Brand Name: 1-DAY ACUVUE TRUEYE (NARA A)
• Type of Device: LENSES, 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 Key: 7026237
• MDR Text Key: 91917510
• Report Number: 9617710-2017-05054
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K073485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2021
• Device Catalogue Number: 1D4
• Device Lot Number: 5824650110
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2016
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention