MAUDE Adverse Event Report: JOHNSON AND JOHNSON VISION CARE, INC CONTACT LENSES, ACUVUE; LENS, SOFT CONTACT, DAILY WEAR

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problems Scarring (2061); Loss of Vision (2139); Viral Infection (2248); Fungal Infection (2419)

Event Date 06/30/2018

Event Type  Injury  

Event Description

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 canadian 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.Fda safety report id # (b)(4).

• Brand Name: CONTACT LENSES, ACUVUE
• Type of Device: LENS, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON AND JOHNSON VISION CARE, INC
• MDR Report Key: 8837092
• MDR Text Key: 152755279
• Report Number: MW5088406
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 29 YR
• Patient Weight: 59