MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. 1 DAY ACUVUE MOIST CONTACT LENSES; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number 137873 0120 00000269

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Red Eye(s) (2038); Viral Infection (2248)

Event Date 03/07/2019

Event Type  Injury  

Event Description

I went to the primary care dr because i was experiencing severe eye irritation (general redness and with a red circle around my iris, and "watering" or weeping eye) in my right eye.The primary care dr referred me to my eye dr for an urgent consultation.I was given a diagnosis of a viral eye infection in my right eye.After two weeks of wearing glasses so my eye could heal.I started trying to transition back to contacts, but the condition worsened every time i wore contacts.I began to wonder if the contacts themselves were the issue.(my prescription is different for each eye, so the contacts for my right eye are not the same as for my left.My left eye remained unaffected.) for ten days i tried wearing other contacts that i had (in my purse or gym bag) and that were from a different lot.I found that i can wear contacts from other lots with no issue, but if i try to wear contacts from this particular lot, my eye becomes red and inflamed again.I suspect something is amiss with this particular lot of contact lenses.I saw both a primary car dr and my eye dr on this date.My eye dr (b)(6), diagnosed a viral eye infection.Fda safety report id# (b)(4).

• Brand Name: 1 DAY ACUVUE MOIST CONTACT LENSES
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC.
• MDR Report Key: 8527331
• MDR Text Key: 142481349
• Report Number: MW5085956
• Device Sequence Number: 0
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/15/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2023
• Device Lot Number: 137873 0120 00000269
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR