MAUDE Adverse Event Report: JOHNSON & JOHNSON ACUVUE OAYSIS; CONTACT LENS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Red Eye(s) (2038); Increased Sensitivity (2065); Blurred Vision (2137); Loss of Vision (2139)

Event Date 10/29/2014

Event Type  Injury  

Event Description

I was using accuvue oasis contacts, which whenever i first put them in i noticed that they were always blurry like they were covered in a film like substance.They constantly bothered my eyes upon initially putting them in.After a week or so this problem would slowly subside.Eventually i noticed that i was suffering from light sensitivity especially when exposed to sunlight and working on my computer, which i am required to do for work.My eyes were red and inflamed so i had to go to the eye doctor.When i went in my corneas were infected and i had white blood cells in my corneas due to my contacts.Cornea infections are a big deal and it could have caused problems with my eyesight/loss of my eyesight.Thankfully this did not occur.I did report this to accuvue and nothing was done about it and the issue is yet resolved.I have heard from my eye doctor that these contacts specifically have caused many infections.If this is the case why are you allowing them on the market.Not only am i a consumer but i am also a healthcare professional and i do not take it lightly that such a product was allowed into the market.I buy products for surgery on a daily basis and these contacts should be recalled/discontinued due to possible patient harm/blindness.

• Brand Name: JOHNSON & JOHNSON ACUVUE OAYSIS
• Type of Device: CONTACT LENS
• MDR Report Key: 4342852
• MDR Text Key: 5174069
• Report Number: MW5039644
• Device Sequence Number: 1
• Product Code: LPL
• 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: 12/10/2014

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 53