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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoxia (1918); Irritation (1941); Keratitis (1944)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018 an email was received from a patient (pt) who reported while using the 1-day acuvue trueye brand contact lenses, the pt experienced irritation, light sensitivity and a vision decrease.Pt went to the eye care provider (ecp) who advised the pt to discontinue contact lens wear.Pt reported the ophthalmologist thought the issue may have been fuch¿s dystrophy.Pt was referred to a cornea specialist who advised the issue was due to ill-fitting contact lenses.The pt had just begun wearing the lenses for a week or two before the symptoms started.On (b)(6) 2018 a call was received from the pt and additional information was provided: pt reported irritation os with the symptoms beginning in (b)(6) 2018.Pt reported the ¿os vision was not good¿, the va dropped to 20/60 and went to the ecp for evaluation.The ecp advised the pt to discontinue contact lens wear, but didn¿t think edema was related to the lenses.Pt was referred to a cornea specialist who advised the pt that the edema was ¿likely caused by poorly fitting contact lenses¿.Pt reported the os va dropped to 20/60.Pt reported that it took a month to recover.Pt was prescribed muro 128 saline drops and ointment for several weeks to decrease the corneal edema.On (b)(6) 2018 a call was placed to the pts ecp with additional information provided: -spoke with ecp who stated after prescribing the 1-day trueye lenses, the pt was diagnosed with punctate keratitis and keratitis sicca due to contact lenses over wear.The pt was advised to discontinue contact lens wear and prescribed 1 drop muro-128, pazeo allergy drops and lubricating drops (frequency and duration were not provided).The ecp stated pt¿s vision is variable and there no permanent issues in visual acuity, but the va fluctuates between 20/40 to 20/60.Ecp reported va correction with lenses or glasses is 20/20/ -1; the ecp reported the pt will continue to have variable acuity and symptoms will continue to worsen while wearing cls since pt does not want to use glasses.The pt was refit in the 1-day moist brand contact lenses and is doing well.On (b)(6) 2018 the pt's medical records were received from the cornea specialist: -date of visit: (b)(6) 2018; contact lens over-wear; mild lscd (limbal stem cell deficiency); noted discomfort with os cl after changing to j&j brand - "never got used to them"; then va decreased os and seen by prescribing ecp who started muro 128, no cl wear; now va back to baseline, but ¿mrx¿ fluctuating since out of cls; wore cls 12-16 hrs/day, no sleeping in them; recommend: cl holiday, when cl wear resumed limit cl wear to 8-10 hrs/day; start pfat's q1-2 hrs, warm compresses and lid hygiene; referred here for possible fuchs endothelial dystrophy: -ecc looks normal; k edema was likely due to hypoxia from cls; h/o herpetic keratitis os.On 03jul2018 an email was received from a representative at the cornea specialist office with additional information: -the pt had contact lens over-wear with early changes at the limbus in the left eye.No additional medical information was provided.Multiple attempts have been made to the pts treating cornea specialist, but no additional information has been received.The suspect os contact lens 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 5629140110 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.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: 7707839
• MDR Text Key: 114812404
• Report Number: 9617710-2018-05043
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K073485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2022
• Device Catalogue Number: 1D4
• Device Lot Number: 5629140110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention