MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ACUVUE OASYS CONTACTS; LENSES, SOFT CONTACT, EXTENDED WEAR

Patient Problem Blurred Vision (2137)

Event Date 12/15/2023

Event Type  Injury  

Event Description

I placed an order for new contacts with my optometrist.6 month supply (b)(6).They are blurry after half an hour.I looked it up and it's apparently common with this brand.I called my eye doctor who will not let me return or exchange them as now my prescription expired so i'm not allowed to return or exchange them.I ordered them on (b)(6) 2023 and called the day after i received them on (b)(6) 2023.I had no chance to return them at all.Contacts are the acuvue oasys brand.It is a brand i have used for years and started having issues last year which seems to be what everyone else experienced.I brought it up to my dr.At my last appointment who told me to change my solution which did not help the situation.

• Brand Name: ACUVUE OASYS CONTACTS
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC.
• MDR Report Key: 18365451
• MDR Text Key: 331085880
• Report Number: MW5149403
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Female