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 Corneal Scar (1793); Fungal Infection (2419)

Event Date 06/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On 09aug2019, during a review of the federal and drug administration (fda) maude website it was noted that a patient (pt) filed a report, medwatch # mw5088406: ¿im a healthy, (b)(6) female.I wore daily contact lenses about twice a week and for special occasions or vacations for about two years.I was never made aware of the dangers of using contacts in regards to water.The optometry clinic nor the contact package gave a warning about why contact lenses shouldn't be in contact with water.Because of contact lenses and tap water i got a viral infection in both eyes that also led to a fungal infection.It was as simple as washing my face while wearing contact lenses.I've had vision all my life and due to this severe infection causing major scarring, i went blind in the right eye in (b)(6) 2018 and then blind in the left eye by (b)(6) 2018.After the worst pain and fight of my life, and 3 cornea transplants (one in the right, two in the left) and just about a year of night mare experiences, i have most of my sight in both eyes again.I was blind in both eyes for 4 months, and the left was blind for about 9 months.All of this came from a viral and fungal infection brought on by contact lenses and local tap water.It was as simple as washing my face or showering after work while wearing contacts.I'd like to raise awareness for eye safety in regards to contact lenses and water use because nobody should have to go through what i did if they only knew the dangers i was never warned about.Too many people have no idea.Too many think it won't happen to them because we are (b)(6) or american and have clean water, or they wear the daily use contacts, or have great hygiene practices.I'm living proof it can happen, and will happen to someone else regardless of all the because i was never warned.¿ no patient contact information was available.The event date is noted as (b)(6) 2019.No further information was received.On 19aug2019, a letter was received from the fda with the mw # 5088406 which provided the pt¿s contact information.The pt was noted to have a (b)(6) address.Additional medical information was also received: ¿concomitant medical products: rx meds: prednisone 5 mg daily, hylo eye drops one drop four times a day in both eyes, prednisolone eye drops one drop four times a day in both eyes, moxifloxacine eye drops one drop four times a day in left eye and one drop a day in right eye.¿ multiple attempts were made to contact the pt to obtain additional information.No additional information has been received.Product name and lot # are unknown.It is unknown if the suspect product is available for return.No product or lot information was available.No analysis could be conducted.This report is for the right eye (od) event.A separate report will be filed for the left eye (os) event.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 20sep2019 during a file review it was noted that there was a date error on the initial mdr # 1057985-2019-00079 submitted on 29aug2019.¿the event date is noted as (b)(6) 2019.¿ should be ¿the event date is noted as (b)(6) 2018.¿ this report is for the right eye (od) event.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 29aug2019, additional information was received from the patient (pt): the pt reported wearing 1-day acuvue® trueye® (nara a) brand contact lenses (cl) right eye (od) at the time of the event.The pt had the od corneal transplant on (b)(6) 2018.The pt reported that the treating doctors thought the cause was a ¿virus or a fungus.¿ a culture taken on (b)(6) 2019 was positive for ¿a parasite.¿ the pt reported the treating doctors are not sure if the ¿organism¿ came from water, dirt, or the cls.The pt could not provide the medications prescribed at this time.The pt had many treating doctors and agreed to send the contact information for each along with medications prescribed.The pt agreed to release medical records.No additional information has been received.This report is for the od event.A separate report will be filed for the os event.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 5058920103 was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

• 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 FL ; EI
• MDR Report Key: 8947266
• MDR Text Key: 160891016
• Report Number: 1057985-2019-00079
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• PMA/PMN Number: K073485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2022
• Device Catalogue Number: 1D4
• Device Lot Number: 5058920103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention